WILMINGTON, Del. / Mar 27, 2023 / Business Wire / Positive high-level results from the NEURO-TTRansform Phase III trial in patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) showed eplontersen met its co-primary endpoints through 66 weeks. The results were consistent with the positive 35-week findings announced in June 2022.1 At 66 weeks, patients treated with eplontersen continued to demonstrate a...Read more
California’s Desert Oasis Healthcare (DOHC) implements Rimidi’s Respiratory Module for respiratory patient monitoring, based on data collected by Teva’s Digihaler® System Digihaler is the first and only smart inhaler system that can provide objective data to help patients and their doctors better support asthma management Teva and Rimidi look to expand respiratory monitoring program to additional health systems with the aim of...Read more
WOBURN, MA / ACCESSWIRE / March 27, 2023 / Biofrontera Inc. (NASDAQ:BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, today announced that it is executing on the company's stated plans to invest in and meaningfully grow its' salesforce in 2023. "With this investment in the salesforce, Biofrontera is taking an important step forward in our growth strategy," stated Erica Monaco, Chief...Read more
WIXOM, Mich. / Mar 27, 2023 / Business Wire / Rockwell Medical, Inc. ("the Company") (Nasdaq: RMTI), a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products to dialysis providers worldwide, announced that it will showcase its hemodialysis concentrates portfolio at DialysisTechConneXion40 ("DTX40"). Hosted by the National Association of Nephrology Technicians/Technologists, DTX40...Read more
SANTA BARBARA, Calif., March 27, 2023 /PRNewswire/ -- Bloomios, Inc. (the "Company") (OTCQB: BLMS), a leading white-label and private-label manufacturer and wholesaler of hemp-derived nutraceutical, cosmetics and pet products, has appointed Upexi's former production division operations head, Joe Reid, as chief manufacturing officer of Bloomios' wholly owned subsidiary, Bloomios Private Label. Reid brings to Bloomios more than a...Read more
GRANT FROM THE BILL & MELINDA GATES FOUNDATION SUPPORTS EVOTEC'S EFFORTS TO DISCOVER AND DEVELOP DRUG CANDIDATES FOR A UNIVERSAL, SHORTER, SAFER AND SIMPLER TUBERCULOSIS DRUG REGIMEN AS ONE OF ITS PROGRAMMES CONTRIBUTING TO THE UN SUSTAINABLE DEVELOPMENT GOAL 3 "WORLD TUBERCULOSIS DAY", 24 MARCH RAISES PUBLIC AWARENESS ABOUT DEVASTATING HEALTH, SOCIAL AND ECONOMIC CONSEQUENCES OF THE TUBERCULOSIS EPIDEMIC HAMBURG, GERMANY /...Read more
A significantly higher proportion of patients with moderately to severely active ulcerative colitis treated with risankizumab achieved the primary endpoint of clinical remissiona (per Adapted Mayo Score) compared to placebo at week 12 in the Phase 3 INSPIRE induction study All secondary endpoints, including clinical, endoscopic and histologic outcomes, were met Safety results in this study were consistent with the known safety profile...Read more
Results of the M19-130 (SLEek) Phase 2 trial of upadacitinib given alone or as a combination therapy (ABBV-599) met the primary endpoint of systemic lupus erythematosus (SLE) Responder Index (SRI-4) and steroid dose less than or equal to 10 mg prednisone equivalent once per day at week 24 in patients with moderately to severely active SLE1,2 No new safety signals were identified with upadacitinib, and a similar safety profile was...Read more
VANCOUVER, British Columbia, March 23, 2023 (GLOBE NEWSWIRE) -- Lucy Scientific Discovery Inc. (“Lucy” or “The Company”) [NASDAQ:LSDI], a leading NASDAQ-listed psychedelic drug manufacturer, announced today the launch of a new line of unscheduled psychoactive compounds that will be available for sale throughout the United States, and where permitted throughout the rest of the world. The first line in the new family of brands contains...Read more
SOLANA BEACH, Calif., March 23, 2023 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, and EVERSANA Life Science Service LLC, an independent provider of global commercial services to the life science industry, today announced a summary of real-world data on the...Read more
2022 and Recent Highlights: Full-year 2022 revenues of $88.6 million, up 22% over full-year 2021 revenues of $72.5 million Sold all non-ophthalmology assets, making Harrow a pure-play ophthalmic pharmaceutical company FDA approval of IHEEZO™ topical ocular anesthetic CMS issuance of Permanent J-Code (J2403) and Pass-Through Reimbursement Status for IHEEZO Acquired U.S. commercial rights to ILEVRO®, NEVANAC®, VIGAMOX®, MAXIDEX®, and...Read more
MONTREAL, March 23, 2023 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) ("Knight" or “the Company”), a leading Pan-American (ex-US) specialty pharmaceutical company, today reported financial results for its fourth quarter and year ended December 31, 2022. All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified. Financial information as at and for the...Read more
CAMBRIDGE, Mass., March 22, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced today the outcome of the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee meeting on tofersen, an investigational product for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). On the question, “Is the available evidence sufficient to conclude that a...Read more
Transaction Expected to Close in Q2 2023 Dublin, Ireland, March 22, 2023 Amryt Pharma Plc (“Amryt”) (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing, and commercializing novel treatments for rare diseases, is pleased to announce that all resolutions presented to shareholders at today’s shareholder meetings held to consider and vote on the proposed acquisition of Amryt by Chiesi...Read more
NORTH CHICAGO, Ill., March 22, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson's disease. In its letter, the FDA requested additional information about the device (pump) as part of the NDA...Read more
DUBLIN, Ireland, March 22, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced that the U.S. Food and Drug Administration (“FDA”) has approved its Pre-Launch Activities Importation Requests (PLAIR) for LUMRYZ. Through its PLAIR, Avadel is authorized to import unapproved drug product into the U.S. ahead of anticipated final...Read more
TORONTO and CHICAGO, March 22, 2023 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (TSX: MDP; OTCQX: MEDXF) is pleased to announce that the company has secured Canadian rights to commercialize terbinafine hydrochloride nail lacquer supplied by Polichem, an Almirall group company focused on medical dermatological treatments for skin health. The product, which Medexus will submit for Health Canada approval later this year, has been...Read more
ROCKVILLE, Md., March 22, 2023 /PRNewswire/ -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), today announced it has entered a research agreement with Georgetown University focused on the evaluation of the Company's lead HDAC6 inhibitor candidate, SP-2-225, evaluating the...Read more
Dosing In Human Clinical Trial To Commence Within Weeks Vancouver, British Columbia--(Newsfile Corp. - March 22, 2023) - Lobe Sciences Ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a North American Biopharmaceutical company committed to discovering and developing patient-focused medicines for Orphan and Rare diseases today announced that its exclusive commercial manufacturing partner has received their initial 2023 quota...Read more
NEW YORK, March 22, 2023 (GLOBE NEWSWIRE) -- LifeMD, Inc. (NASDAQ: LFMD), a leading direct-to-patient telehealth company, today announced that the Company closed on a new senior secured credit facility with Avenue Capital. The credit agreement, which matures on October 1, 2026, provides up to $40 million in total term loan capital including a first tranche of $15 million funded at closing, a second tranche of $5 million of committed...Read more
Achieved consolidated Adjusted EBITDA profitability for first-time in LifeMD history Full Year 2022 consolidated revenue of $119.0 million, up 28% from the same year-ago period. Fourth quarter 2022 consolidated revenue of $28.1 million up 3% from the same year-ago period. This figure was impacted by a $2.9 million deferral of telehealth shipments. Adjusted EPS of $0.02, 107% improvement versus the prior year. Subsequent to year end,...Read more
Fourth Quarter 2022 Net Revenue Increased 33% from Third Quarter 2022 While GAAP Quarter-Over-Quarter OPEX Decreased 55% and Non-GAAP OPEX Remained Unchanged Twirla Demand and Factory Sales Up 25% and 30% Respectively in Fourth Quarter 2022 vs Third Quarter 2022 Company Reaffirms Expected Full Year 2023 Net Revenue in Range of $25-$30 Million Management to Host Conference Call Today, Wednesday, March 22, 2023 at 4:30 p.m....Read more
SANTA MONICA, Calif. / Mar 21, 2023 / Business Wire / Kite, a Gilead Company (Nasdaq: GILD), today announced the primary overall survival (OS) analysis results of the Phase 3 ZUMA-7 study. The results showed a statistically significant improvement for Yescarta in OS versus historical treatment, which was the standard of care (SOC) in a curative setting for nearly 30 years, for initial treatment of adult patients with relapsed/refractory...Read more
Transaction subject to Wesana shareholder approval and expected to close in Q2 2023 SANA-013 combination of psilocybin and CBD being developed for potential treatment of mental health/CNS conditions expected to commence human testing in 2023 Development costs are expected to be borne by a financial partner VANCOUVER, British Columbia, March 21, 2023 (GLOBE NEWSWIRE) -- Lucy Scientific Discovery Inc. (“Lucy” or “The...Read more
Findings from a retrospective analysis suggest that treatment with Acthar Gel is associated with significant reductions in corticosteroid use compared to other fourth-line alternatives for patients with advanced sarcoidosis1 DUBLIN , March 21, 2023 /PRNewswire/ -- Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today announced that an abstract highlighting results from a retrospective...Read more
Proceeds from the financing commitment will be used to enhance the launch and commercialization of Scilex’s three FDA-approved non-opioid pain management products (ZTlido®, Gloperba® and Elyxyb™) for the treatment of acute and chronic pain. The financing will enable further investment in Scilex’s non-opioid pain management portfolio, accelerating its mission to launch innovative non-opioid pain management products in major...Read more
CUPERTINO, Calif., March 21, 2023 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today that Gail Maderis has assumed the role of Chair of the Board of DURECT effective March 17, 2023. Ms. Maderis succeeds David Hoffmann as Chair of the Board. Mr. Hoffman has decided not to stand for re-election and will retire from the board on June 21, 2023 when his current term as a board member expires. "We thank Dave...Read more
MISSISSAUGA, Ontario, March 21, 2023 (GLOBE NEWSWIRE) -- BioSyent Inc. (“BioSyent”, TSX Venture: RX) released today its financial results for the three and twelve months ended December 31, 2022. Key highlights include: Fourth quarter (Q4) 2022 Total Company Net Revenues of $7,461,930 increased by 3% versus Q4 2021 Q4 2022 Total Company Net Revenues from continuing brands increased by 15% versus Q4 2021 (excluding brands...Read more
Fiscal year 2022 net product sales from prescriptions increased by 179% to $2.5 million versus 2021 Patient enrollment increased by 149% compared with 2021 SOLANA BEACH, Calif., March 21, 2023 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, today announced its...Read more
SOUTH SAN FRANCISCO, Calif. / Mar 20, 2023 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new long-term data for Evrysdi® (risdiplam) in a broad range of people aged 2-25 years with spinal muscular atrophy (SMA) from the pivotal SUNFISH study. Data confirm increases in motor function were sustained at four years and the overall rate of adverse events continued to decrease over the...Read more
Cash proceeds to be allocated to near term pharmacy acquisitions TORONTO, March 20, 2023 /CNW/ - Neighbourly Pharmacy Inc. (TSX: NBLY) ("Neighbourly" or the "Company"), Canada's largest and fastest growing network of independent pharmacies, is pleased to announce that the Company has completed the planned divestiture of 18 real estate properties which had been acquired as part of the Rubicon acquisition. The net proceeds of...Read more
SAN DIEGO, Calif. and GAINESVILLE, Ga., March 20, 2023 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (“Societal CDMO” or “Societal”; NASD: SCTL), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that the United States Food and Drug Administration (FDA) has approved the company as a manufacturer...Read more
Ten presentations at the International Conference on Alzheimer’s & Parkinson’s Diseases (AD/PDTM) AC Immune’s Chief Medical Officer to participate in expert forum on immunotherapies in Alzheimer’s disease Lausanne, Switzerland, March 20, 2023 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that ten presentations will be...Read more
Exploring a range of strategic alternatives Revenues from product sales from continued operations increased +27% Y/Y in 4Q 2022 and +33% for full year 2022 Net Loss attributable to Athenex was $34.2 million, or $4.28 per diluted share in 4Q2022, compared to $104.4 million, or $19.08 per diluted share, in the prior year quarter Cash, cash equivalents, and restricted cash balance of $35.6 million at year end Additional Phase 1 dose...Read more
GAINESVILLE, Fla. / Mar 20, 2023 / Business Wire / Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today reported its financial results for the full year 2022 and provided a business update. “We continue to be extremely active and engaged with...Read more
Treatment with SKYRIZI (risankizumab) demonstrated short- and long-term efficacy of psoriasis signs and symptoms (sPGA 0/1) at week 16 and week 52 in a difficult-to-treat population, with no new safety signals observed in an open-label, single-arm phase 3b study Patients with moderate to severe psoriasis previously received at least six months of treatment with secukinumab or ixekizumab with a suboptimal response, defined as a static...Read more
OSAKA, Japan & CAMBRIDGE, Mass. / Mar 18, 2023 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced positive results from a Phase 2b clinical trial of TAK-279 (NDI-034858), a highly selective, oral allosteric tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate-to-severe plaque psoriasis. The study met its primary and secondary endpoints, with a statistically significant greater proportion of TAK-279 patients achieving...Read more
CHICAGO, IL / ACCESSWIRE / March 17, 2023 / Cosmos Health Inc. ("Cosmos Health" or "the Company") (Nasdaq:COSM), a global healthcare group with proprietary lines of nutraceuticals and distributor of pharmaceuticals, branded generics, OTC medications and medical devices, announced today that it has entered into a definitive agreement to acquire ZipDoctor Inc. from American International Holdings Corp (AMIH) for an undisclosed sum. The Sale...Read more
VICTORIA, British Columbia and VANCOUVER, British Columbia, March 17, 2023 (GLOBE NEWSWIRE) -- Lucy Scientific Discovery Inc. (“Lucy” or “The Company”) [NASDAQ:LSDI], an early-stage psychedelics manufacturing company, announced today that it has partnered with Pramantha Group, a firm specializing in securing key government contracts and grants, to enhance its drug manufacturing capabilities and meet the growing demand for essential...Read more
Alvotech to present two posters related to pharmacokinetics and confirmatory clinical studies for AVT04 (ustekinumab), a proposed biosimilar to Stelara® Marketing applications for AVT04 have been submitted in major markets including U.S. and Europe REYKJAVIK, Iceland, March 17, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for...Read more
ANN ARBOR, MI / ACCESSWIRE / March 17, 2023 / Zomedica Corp. (NYSE American:ZOM) ("Zomedica" or the "Company"), a veterinary health company offering point-of-care diagnostics and therapeutic products for companion animals, announced that it has appointed Peter L. Donato as its Chief Financial Officer, effective March 16, 2023. Mr. Donato brings over 30 years of public and private company experience in a wide range of finance and...Read more
Pfizer and Astellas announce positive topline results from Phase 3 EMBARK trial NEW YORK and TOKYO, March 16, 2023 /PRNewswire/ -- Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced positive topline results from the Phase 3 EMBARK trial evaluating XTANDI® (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer...Read more
RAHWAY, N.J. / Mar 16, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today provided an update on the open-label arm of the non-registrational Phase 2 KeyVibe-002 trial. KeyVibe-002 is evaluating MK-7684A, a coformulation of vibostolimab, an anti-TIGIT therapy, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy, with or without docetaxel for the treatment of patients with metastatic...Read more
NEW YORK / Mar 16, 2023 / Business Wire / Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted 16 to 1 that available data support the safety and effectiveness of PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adult patients who are at high risk for progression to severe illness. The AMDAC's...Read more
Subjects completed 16-week treatment with no significant safety issues Topline results expected in the first half of 2023 SCOTTSDALE, Ariz., March 16, 2023 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage biopharmaceutical company that focuses on the development and commercialization of pharmaceutical products for the treatment of dermatological conditions, today announced...Read more
TEL AVIV, Israel, March 16, 2023 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today provided a business update for the year ended December 31, 2022. Ilan Hadar, Chief Executive Officer, stated, “We are pleased to report a number of important milestones this past year which have helped advance...Read more
CAMBRIDGE, Mass., March 16, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the Court of Justice of the European Union decided in favor of Biogen, the European Medicines Agency (EMA), and the European Commission in their appeal of a General Court decision annulling the EMA’s refusal to evaluate a generic version of TECFIDERA® (dimethyl fumarate) because of TECFIDERA’s regulatory data and marketing protection....Read more
Highlights: Incannex plans to open multiple psychedelic-assisted psychotherapy clinics in Australia and overseas. First clinic will open in Melbourne in 2023, followed by rapid expansion based on development of sound operating model. Dr. Paul Liknaitzky, Professor Suresh Sundram and Sean O’Carroll to join the Board of Directors of a subsidiary company and take key roles within the venture. Incannex owned subsidiary is being led by...Read more
KEY SCIENTIFIC ACHIEVEMENTS DRIVE THE EXPANSION OF THE PIPELINE OF MOLECULAR GLUE DEGRADERS PERFORMANCE-BASED AND PROGRAMME-BASED PAYMENTS OF IN TOTAL US$ 75 M TO EVOTEC HAMBURG, GERMANY / ACCESSWIRE / March 16, 2023 / Evotec SE (Frankfurt Stock Exchange:EVT) (MDAX/TecDAX, ISIN: DE0005664809) (NASDAQ:EVO) today announced progress within the Company's strategic partnership with Bristol Myers Squibb relating to building a molecular...Read more
TORONTO, March 16, 2023 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX: HLS), a pharmaceutical company focusing on central nervous system ("CNS") and cardiovascular markets, announces its financial results for the three- and twelve-month periods ended December 31, 2022. All amounts are in thousands of United States ("U.S.") dollars unless otherwise stated. Q4 & FISCAL 2022 FINANCIAL HIGHLIGHTS 2022 revenue of...Read more
Company Announces Intention to Explore Strategic Alternatives Signs Term Sheet with Key Customer to Materially Expand Commercial Relationship Expands Development Pipeline from 24 to 25 Active Projects as of Fiscal Second Quarter-end Subsequently Transitioned Three Projects to Commercialization with FDA Approval in Fiscal Third Quarter, Expanding Commercial Products from 26 to 29 with 14 Customers Fiscal Second Quarter Earnings Call...Read more
SAN DIEGO, March 16, 2023 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company focused on developing and commercializing products in various therapeutic areas, including opioid overdose, allergy, respiratory and inflammatory disease, today announced financial results for the full year ended December 31, 2022, and provided an update on recent corporate developments. General Corporate...Read more
OTTAWA, Ontario / Mar 16, 2023 / Business Wire / Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhances feed intake and supports immune function, thereby supporting general health and performance, has announced its unaudited financial results for the first quarter of 2023. First Quarter...Read more
BEERSE, Belgium / Mar 15, 2023 / Business Wire / The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) announced today the publication of new data in the journal Nature showing that an early-stage clinical candidate (JNJ-1802) provides strong protection against dengue in non-human primates and mice. The first-in-class antiviral, which was shown to be safe and well tolerated in a Phase 1 first-in-human clinical study, is...Read more
Highlights: Interim analysis of study data to date indicates that there is a greater than 85% chance (>85%, alpha error probability 0.05) of the study showing a statistically significant benefit for the psilocybin treatment arm versus the placebo treatment arm at the conclusion of the study period. An independent Data Safety Monitoring Board (DSMB) has reviewed data from Incannex’s ongoing Phase 2 “PsiGAD” clinical trial and...Read more
HOLLISTER, Calif., March 15, 2023 (GLOBE NEWSWIRE) -- Alpha Teknova, Inc. (“Teknova”) (Nasdaq: TKNO), and Sartorius BIA Separations, which is part of the international life science group Sartorius, today announced that the companies have entered into a collaboration arrangement that will help gene therapy companies streamline the downstream purification process. Teknova is a leading producer of critical reagents for the research,...Read more
ANN ARBOR, MI / ACCESSWIRE / March 15, 2023 / Zomedica Corp. (NYSE American:ZOM) ("Zomedica" or the "Company"), a veterinary health company offering point-of-care diagnostics and therapeutic products for companion animals, today reported consolidated financial results for the year ended December 31, 2022. Amounts, unless specified otherwise, are expressed in U.S. dollars and presented under accounting principles generally accepted in the...Read more
Full year 2022 total revenue was $41.4 million, up 12% year-over-year New, state-of-the-art manufacturing facility now operational Company provides 2023 revenue guidance of $42-46 million HOLLISTER, Calif., March 15, 2023 (GLOBE NEWSWIRE) -- Alpha Teknova, Inc. (“Teknova” or the “Company”) (Nasdaq: TKNO), a leading producer of critical reagents for the research, discovery, development, and commercialization of novel therapies,...Read more
Total Revenues for Fiscal Year 2022 of $129.3 Million Represented Growth of 25% Compared to Fiscal Year 2021; Fourth Quarter 2022 Revenues of $45.4 Million Represented a 44% Increase Year-over-Year Fiscal Year 2022 EBITDA of $17.8 million, Represented Margins of 14%, and a 3x Increase Over Fiscal Year 2021 Recorded Highest Annual Operating Cash Flow in Kamada's History of $28.6 Million in Fiscal Year 2022; $34.3 Million Cash...Read more
Fifth consecutive quarter of revenue growth at $13.2 million in Q1-23, up 210% over Q1-22 Fifth consecutive quarter of adjusted gross profit increase at $4.2 million, up 178% over Q1-22 Fifth consecutive quarter of adjusted EBITDA loss reduction at $2.2 million, a 51% improvement over Q1-22 Physicians prescribing Enerzair and Atectura reached 1,583 at the end of Q1-23, representing 39% growth from the prior quarter and a 799%...Read more
LAVAL, Quebec / Mar 15, 2023 / Business Wire / Crescita Therapeutics Inc. (TSX: CTX and OTC US: CRRTF) (“Crescita” or the “Company”), a growth-oriented, innovation-driven Canadian commercial dermatology company, today reported its financial results for the fourth quarter and fiscal year ended December 31, 2022 (“Q4-F2022” and “F2022”). All amounts presented are in thousands of Canadian dollars (“CAD”) unless otherwise noted. Financial...Read more
ROCKVILLE, Md., March 15, 2023 /PRNewswire/ -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), today provided a corporate update in connection with the filing of its Annual Report on Form 10-K for the year ended December 31, 2022. Recent Highlights Completed an initial public...Read more
DUBLIN / Mar 14, 2023 / Business Wire / Horizon Therapeutics plc (Nasdaq: HZNP) today announced the presentation of new MRI imaging data from the Phase 3 clinical trial showing UPLIZNA reduced the formation of subclinical (asymptomatic) optic nerve lesions in people with NMOSD. These findings are being presented during the 49th annual meeting of the North American Neuro-Ophthalmology Society (NANOS) March 11-16, 2023, in Orlando,...Read more
TEL AVIV, Israel, March 14, 2023 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced that it has commenced a Phase 3 clinical trial of PRF-110, the Company’s lead drug candidate, targeting the post-operative extended pain relief market. The Phase 3 trial is a randomized, double-blind,...Read more
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., March 14, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM, HKEX:13) today announces that, further to its announcement on January 23, 2023 and following the completion of customary closing conditions including antitrust regulatory reviews, the exclusive license agreement with a subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502, NYSE:TAK) to...Read more
Novo Nordisk has been working to identify a sustainable approach to reduce insulin costs for patients that addresses changes in health policy and market shifts Lower list prices build on long-standing history of affordability initiatives already in place which can be accessed at NovoCare.com Novo Nordisk currently provides co-pay support for a number of insulin products meaning eligible patients can pay $25-35 for their insulin...Read more
Agreement with Alora Pharmaceuticals provides AcelRx with 15% royalties on commercial sales, 75% royalties on Department of Defense (DoD) sales, up to $116.5 million in potential sales-based milestone payments, and a strong commercial partner experienced with commercialization in hospital settings Divestment allows AcelRx to prioritize resources on its late stage development assets, led by Niyad™, the lead nafamostat program with...Read more
INDIANAPOLIS, March 14, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that data from its oncology portfolio will be presented at the American Association for Cancer Research (AACR) Annual Meeting in Orlando, April 14 – 19, 2023. The presentations include the first clinical data from the Phase 1 studies of LY3537982 (KRAS G12C inhibitor) and LY3410738 (IDH inhibitor) and the Phase 2 study of Verzenio® (abemaciclib;...Read more
Data show that sudocetaxel zendusortide (TH1902) can induce tumor infiltrating lymphocytes and potentiate anti-PD-L1 immunotherapy in a melanoma mouse model Two other studies highlight activity of TH1902 in SORT1+ triple-negative and HER2+ breast cancers, as well as high expression of SORT1 in various tumor types, compared with healthy tissues MONTREAL, March 14, 2023 (GLOBE NEWSWIRE) -- Theratechnologies Inc....Read more
PHOENIX, March 14, 2023 (GLOBE NEWSWIRE) -- MedAvail Holdings, Inc. (Nasdaq: MDVL) (“MedAvail”), an innovative pharmacy technology company, today announced that on March 13, 2023, it closed a private placement (the “Offering”) of securities with certain institutional investors pursuant to the terms of a definitive securities purchase agreement dated March 9, 2023. The Offering consists of pre-funded warrants to purchase common stock...Read more
SAN DIEGO, March 14, 2023 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a commercial-stage biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including opioid overdose, allergy, respiratory and inflammatory disease, today announced it has entered into a securities purchase agreement with a single, healthcare-focused institutional investor for...Read more
XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) significantly delays time to PSA progression compared to placebo plus ADT Study enrolled 180 men with metastatic hormone-sensitive prostate cancer in mainland China TOKYO, March 13, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced positive topline results from the Phase 3 China ARCHES study...Read more
NEW YORK & BOTHELL, Wash. / Mar 13, 2023 / Business Wire / Pfizer Inc. (NYSE: PFE) and Seagen Inc. (Nasdaq: SGEN) today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Seagen, a global biotechnology company that discovers, develops and commercializes transformative cancer medicines, for $229 in cash per Seagen share for a total enterprise value of $43 billion. The Boards of Directors...Read more
NASHVILLE, Tenn. / Mar 13, 2023 / Business Wire / Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced that the Centers for Medicare & Medicaid Services (CMS) has approved transitional pass-through reimbursement status for IHEEZO™ (chloroprocaine hydrochloride ophthalmic gel) 3%, which is indicated for ocular surface anesthesia. Beginning April 1, 2023, and for the three years thereafter, IHEEZO will be...Read more
More than 20 abstracts, including one late-breaking presentation, underscore AbbVie's dedication to advancing care for dermatologic conditions NORTH CHICAGO, Ill., March 13, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it will present more than 20 abstracts, including one late-breaking presentation during the 2023 American Academy of Dermatology (AAD) Annual Meeting, March 17-21, in New Orleans, Louisiana. "The...Read more
Presentation to be given in Collaboration with the Mayo Clinic at the United States and Canadian Academy of Pathology (USCAP) Annual Meeting Company’s findings to be presented in a headline Poster on March 14th at the premiere global pathology conference. Garden City, NY, March 13, 2023 (GLOBE NEWSWIRE) -- ProPhase Labs, Inc. (NASDAQ: PRPH) (“ProPhase”), a growth oriented and diversified diagnostics, genomics and...Read more
• Q4 2022 net income was $0.63 per basic and $0.62 per diluted share and adjusted non-GAAP net income was $1.11 per basic and $1.10 per diluted share1 • Total revenue for Q4 2022 was $60.7 million, compared to $42.3 million in Q4 2021 • FY 2022 net income was $2.76 per basic and $2.73 per diluted share and adjusted non-GAAP net income was $7.87 per basic and $7.79 per diluted share1 • FY 2022 revenue was $316.6 million compared to...Read more
NEW YORK / Mar 10, 2023 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) has approved ZAVZPRET™ (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults. In its pivotal Phase 3 study, ZAVZPRET was statistically superior to placebo on the co-primary endpoints of pain freedom...Read more
RAHWAY, N.J. & KINGSTON, Ontario / Mar 10, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and the Canadian Cancer Trials Group (CCTG) today announced that the Phase 2/3 CCTG IND.227/KEYNOTE-483 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met its primary endpoint of overall survival (OS) for the first-line treatment of patients with unresectable...Read more
SOUTH SAN FRANCISCO, Calif. / Mar 09, 2023 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 11 to 2 in favor of Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously...Read more
WILMINGTON, Del. / Mar 09, 2023 / Business Wire / Positive high-level results from a planned interim analysis of the AEGEAN Phase III, placebo-controlled trial showed that treatment with AstraZeneca’s IMFINZI® (durvalumab) in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) versus...Read more
WILMINGTON, Del. / Mar 09, 2023 / Business Wire / Positive high-level results from the ADAURA Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), a key secondary endpoint, compared to placebo in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell...Read more
PARSIPPANY, N.J. & TEL AVIV, Israel & HYDERABAD, India / Mar 09, 2023 / Business Wire / Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816), announced today the launch of additional strengths for the generic version of Revlimid®1 (lenalidomide capsules), in 2.5 mg, and 20 mg strengths, in the United States. The companies have...Read more
ROCKVILLE, Md., March 9, 2023 /PRNewswire/ -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), today announced it has signed an agreement with the University of Iowa (UI) Pharmaceuticals for formulation development and clinical batch manufacture of drug capsules of...Read more
WOODCLIFF LAKE, N.J., March 09, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that Scott Tarriff, Chief Executive Officer, and Brian Cahill, Chief Financial Officer, will participate in a fireside chat at the Barclays Global Healthcare Conference, in Miami, FL, as follows: Date: Wednesday, March 15, 2023 Time: 2:35pm ET Webcast: Click Here To...Read more
BAUDETTE, Minn. / Mar 09, 2023 / Business Wire / ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced business highlights and financial results for the three and 12 months ended December 31, 2022. “2022 was a transformative year for ANI, taking us past critical inflection points for our two key growth drivers – the launch of Cortrophin Gel, our foundational Rare Disease asset, and investment in our generics...Read more
Net Product Sales Increase 55% in the Fourth Quarter, 42% for the Full Year Full Year Net Income Increases to $109.6 Million, Non-GAAP Adjusted EBITDA Increases to $101.6 Million Cash Flows from Operations Was $26.7 Million for the Fourth Quarter and $78.6 Million for the Full Year LAKE FOREST, Ill., March 08, 2023 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a specialty...Read more
CH Trading Group will serve as exclusive territories distributor in the Middle East and North Africa countries with US $105 million minimum purchase commitment. CH Trading Group to immediately start the process to expand commercialization of ZTlido® in Middle East and North Africa markets and has the opportunity to distribute across the broader Islamic world and further expand the relationship for other products in Scilex’s non-opioid...Read more
The application is based on phase III results from the DINAMO trial showing Jardiance® (empagliflozin) tablets significantly reduced A1c (a marker of average blood sugar) versus placebo in participants aged 10-17 living with type 2 diabetes If approved, Jardiance would be the first SGLT2 inhibitor indicated for this vulnerable population RIDGEFIELD, Conn. and INDIANAPOLIS, March 8, 2023 /PRNewswire/ -- The U.S. Food and Drug...Read more
RANCHO CUCAMONGA, CA / ACCESSWIRE / March 8, 2023 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) ("Amphastar" or the "Company") announced that the U.S. Food and Drug Administration ("FDA") has granted approval of its New Drug Application ("NDA") for naloxone hydrochloride nasal spray 4mg, which is delivered utilizing the Company's proprietary nasal delivery device. Naloxone hydrochloride nasal spray 4mg is indicated for the emergency...Read more
| Company | Change | Last Trade |
|---|---|---|
| Novartis | 6.12 7.32 | $89.71 |
| Catalent | 3.07 4.78 | $67.34 |
| Merck | 2.40 2.29 | $107.20 |
| ANI Pharmaceuticals | 1.49 3.96 | $39.10 |
| Novo Nordisk | 1.31 0.86 | $154.07 |
| AstraZeneca | 1.21 1.78 | $69.12 |
| Harrow Health | 1.20 6.51 | $19.62 |
| Johnson & Johnson | 1.10 0.72 | $153.75 |
| Zoetis | 0.94 0.57 | $165.12 |
| Supernus Pharmaceuticals | 0.76 2.12 | $36.53 |
| Pacira BioSciences | 0.74 1.89 | $39.88 |
| Bristol-Myers Squibb | 0.74 1.09 | $68.43 |
| AbbVie | 0.57 0.36 | $158.59 |
| GSK | 0.54 1.57 | $34.92 |
| Horizon Therapeutics | 0.49 0.45 | $109.01 |
Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth...
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