A one-time dose of BEQVEZ has reduced bleeds post-treatment compared to standard of care with a median of zero bleeds (range 0 to 19) after up to three years of follow-up, providing sustained bleed protection and potentially avoiding years of treatment burden with prophylaxis for many patients NEW YORK / Apr 26, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved BEQVEZ™ (fidanacogene elaparvovec-dzkt)... Read more
THOUSAND OAKS, Calif., April 26, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the imminent submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for teprotumumab, a fully human monoclonal antibody and targeted inhibitor of the insulin-like growth factor-1 receptor (IGF-1R), for the treatment of moderate to severe Thyroid Eye Disease (TED) in adults. TED is a serious, progressive, debilitating and potentially... Read more
If Approved in the European Union, Fruquintinib Will Be the First Novel Targeted Therapy for Metastatic Colorectal Cancer Regardless of Biomarker Status in Over a Decade
Positive Opinion Based on Results from a Phase 3 Clinical Trial Which Demonstrated Significant Improvements in Overall Survival and Progression Free Survival versus Placebo Plus Best Supportive Care, with Benefit Seen Regardless of Prior Types of Therapy Received OSAKA, Japan & CAMBRIDGE, Mass.... Read more
Additional Data in Pregnant Adults Who Are Virologically Suppressed Reinforce Safety and Tolerability Profile of Biktarvy in Broad Range of People With HIV
Perinatal Guidelines Recognize Biktarvy as Alternative Regimen for Use During Pregnancy and for Those Trying to Conceive FOSTER CITY, Calif. / Apr 26, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) approved an updated label with additional data... Read more
Reports First-Quarter Diluted EPS of $0.77 on a GAAP Basis, an Increase of 492.3 Percent; Adjusted Diluted EPS of $2.31, a Decrease of 6.1 Percent; These Results Include an Unfavorable Impact of $0.08 Per Share Related to Acquired IPR&D and Milestones Expense
Delivers First-Quarter Net Revenues of $12.310 Billion, an Increase of 0.7 Percent on a Reported Basis and 1.6 Percent on an Operational Basis
First-Quarter Global Net Revenues from the Immunology Portfolio... Read more
Recommendation based on results from CheckMate -901, the first Phase 3 trial with an immunotherapy-chemotherapy combination to demonstrate a survival benefit versus standard-of-care chemotherapy alone in cisplatin-eligible adults with unresectable or metastatic urothelial carcinoma
If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU
A decision on the EU marketing authorization is... Read more
Strong revenue performance across product portfolio
Submitted MAA for sepiapterin and BLA for Upstaza
On target to achieve remaining 2024 clinical and regulatory milestones, including global submissions for sepiapterin WARREN, N.J., April 25, 2024 /PRNewswire/ -- PTC Therapeutics, Inc., (NASDAQ: PTCT) today announced a corporate update and financial results for the first quarter ending March 31, 2024.
"We are off to a strong start in... Read more
CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE™ to the reference product ROACTEMRA® CAMBRIDGE, Mass., April 25, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for TOFIDENCE™ (tocilizumab), a biosimilar monoclonal antibody referencing ROACTEMRA®1.... Read more
Product Sales Excluding Veklury Increased 6% Year-Over-Year to $6.1 billion
Biktarvy Sales Increased 10% Year-Over-Year to $2.9 billion
Oncology Sales Increased 18% Year-Over-Year to $789 million
Closed CymaBay Acquisition Resulting in $3.9 billion Acquired IPR&D Charge ($3.14 Diluted EPS Impact) FOSTER CITY, Calif. / Apr 25, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) announced today its first quarter 2024 results of operations.
“Gilead delivered... Read more
SCOTTSDALE, Ariz., April 25, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (“Journey Medical” or “the Company”) (Nasdaq: DERM), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, announced today that Claude Maraoui, Co-Founder, President and Chief Executive Officer, will present... Read more
MIAMI, FL, April 25, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced that the Company will present two late-breaking abstract presentations at the American Association of Clinical Endocrinology (AACE) 2024 Annual Meeting, taking place May 9-11, 2024... Read more
LAKE FOREST, Ill., April 25, 2024 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients, today announced that it will release first quarter 2024 financial results on Monday, May 6, 2024, after the market close. Following the release of its financial results, Assertio’s management will host a live webcast of the earnings... Read more
Upadacitinib demonstrated superiority versus dupilumab in primary endpoint of simultaneous achievement of near complete skin clearance (EASI 90) and no to little itch (WP-NRS 0/1) at Week 161
LEVEL UP, a Phase 3b/4 head-to-head study, compared upadacitinib to dupilumab for the treatment of adult and adolescent patients with moderate-to-severe atopic dermatitis who had inadequate response to systemic therapy or when use of those therapies was inadvisable1
The safety... Read more
Garden City, NY, April 25, 2024 (GLOBE NEWSWIRE) -- ProPhase Labs, Inc. (NASDAQ: PRPH), a biopharma, genomics and diagnostics Company, today announced that it will be presenting at the Planet MicroCap Showcase: VEGAS 2024 on Wednesday, May 1, 2024 at 11:30 am PST, 2:30 pm EST. Ted Karkus, CEO, will be hosting the presentation and answering questions at the conclusion.
To access the live presentation, please use the following information:
Planet MicroCap... Read more
Performance Reflects Execution and Actions to Strengthen the Company's Long-Term Growth Profile
First Quarter Revenues were $11.9 Billion, increasing 5% (+6% Adjusting for Foreign Exchange) Growth Portfolio Revenues were $4.8 Billion, increasing 8% (+11% Adjusting for Foreign Exchange) Strengthened Long-Term Growth Profile Through Completion of Karuna Therapeutics, RayzeBio, Mirati Therapeutics, and SystImmune Transactions
Including the One-Time Net Impact of... Read more
YARDLEY, Pa., April 25, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced corporate updates detailing its commercial plans and expectations for XHANCE® (fluticasone propionate) following the recent FDA approval of a new indication for the treatment of chronic rhinosinusitis without nasal polyps in patients 18 year of age and older. The Company will... Read more
Sales Reflect Continued Strong Growth in Oncology and Vaccines
Total Worldwide Sales Were $15.8 Billion, an Increase of 9% From First Quarter 2023; Excluding the Impact of Foreign Exchange, Growth Was 12% KEYTRUDA Sales Grew 20% to $6.9 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 24%
GARDASIL/GARDASIL 9 Sales Grew 14% to $2.2 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 17% GAAP EPS Was $1.87; Non-GAAP EPS Was $2.07; GAAP and... Read more
Proposed Divestment of Branded Prescription Pharma Business Further Supports Perrigo's Strategic Focus on Consumer Self-Care
Total Purchase Consideration of up to €275 Million, Consisting of €190 Million in Cash Upfront and up to €85 Million in Potential Earnouts; Based on 2023 Adjusted EBITDA of ~€20M, Total Consideration Would be Accretive to Perrigo's Current Enterprise Value-to-EBITDA Multiple
Expected Net Proceeds to be Redeployed for Debt Repayment
Expected... Read more
PALO ALTO, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or the “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced the closing of its previously announced registered direct offering of an aggregate of 15,000,000 shares of its common stock, par value $0.0001 per share, and... Read more
Very strong revenue and EPS growth in the first quarter coupled with exciting pipeline delivery CAMBRIDGE, United Kingdom / Apr 25, 2024 / Business Wire / AstraZeneca:
Revenue and EPS summary Q1 2024 % Change
$m Actual CER1 - Product Sales 12,177 15 18 - Alliance Revenue 457 59 &nb... Read more
Walgreens Specialty Pharmacy combines existing specialty assets, fully integrates AllianceRx and represents the company’s latest step to leverage its neighborhood pharmacies into fast-growing areas of healthcare
Investments include new Gene & Cell Services Pharmacy and Innovation Center DEERFIELD, Ill. / Apr 24, 2024 / Business Wire / Walgreens is expanding its specialty pharmacy services and investing in its capabilities as the company further grows its core... Read more
Company launches generic equivalent to OTC NARCAN® Nasal Spray
Provides convenient, affordable access to life-saving medicine BRIDGEWATER, N.J. / Apr 24, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the availability of Over the Counter (“OTC”) Naloxone Hydrochloride (Naloxone HCI) Nasal Spray, USP, 4mg, following Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and... Read more
PALO ALTO, Calif., April 24, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or the “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced that it has entered into a definitive agreement with certain institutional investors for the purchase and sale of an aggregate of 15,000,000 shares of its... Read more
FINANCIAL RESULTS FOR 2023 FULLY MET UPDATED GUIDANCE
PRIORITY RESET TO PROFITABLE GROWTH: SIZE & FOOTPRINT ADJUSTMENTS TO DRIVE EXPECTED ANNUALISED EBITDA IMPROVEMENT GREATER THAN € 40 M
EVOTEC'S REPORTING STRUCTURE WILL CHANGE TO BUSINESS SEGMENTS “SHARED R&D” AND “JUST - EVOTEC BIOLOGICS” STARTING Q1 2024 HAMBURG, GERMANY / ACCESSWIRE / April 24, 2024 / Evotec SE (Frankfurt Stock Exchange:EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ:EVO) today... Read more
WINNIPEG, MB / ACCESSWIRE / April 23, 2024 / Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH) (OTC PINK:MCUJF), a company focused on the development and commercialization of pharmaceuticals and healthcare products for patients and prescribers in the United States market, announced today that through its subsidiary, Medicure International Inc., the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for MC-1, an investigational product for the... Read more
GAITHERSBURG, Md., April 23, 2024 (GLOBE NEWSWIRE) -- 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 that its Chief Executive Officer, Dr. Anatoly Dritschilo, will present at the Planet MicroCap Showcase: VEGAS 2024, on Wednesday, May 1, 2024 at 4:30pm PT. The Company will also host in... Read more
HAMBURG, GERMANY / ACCESSWIRE / April 23, 2024 / The Supervisory Board of Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ:EVO) has appointed Dr Christian Wojczewski as the Company's new Chief Executive Officer ("CEO"), effective 01 July 2024. The election was unanimous and is the result of an extensive selection process that began in January.
Dr Mario Polywka, who has led Evotec as Interim CEO since 03 January 2024, will retire from his... Read more
VANCOUVER, British Columbia, April 23, 2024 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a leading Health Canada licensed psychedelics pharmaceutical manufacturer, is thrilled to announce an innovative research and development partnership with the Kwantlen Polytechnic University Applied Genomics Centre (KPU-AGC). The project, entitled, “Genetic Identification of Psilocybin Containing Mushroom,” will utilize KPU-AGC’s state-of-the-art... Read more
CAMBRIDGE, Mass. and NESS ZIONA, Israel, April 23, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the Company will present data from the Phase 1b/2a study of BX004 for the treatment of cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infections at ECCMID 2024, which... Read more
EMBLAVEO® is the first β-lactam/β-lactamase inhibitor antibiotic combination approved in the European Union for treating serious infections in adult patients caused by multidrug-resistant Gram-negative bacteria, including metallo-β-lactamase-producing bacteria
EMBLAVEO® was reviewed under European Medicines Agency accelerated assessment procedure, used when a pharmaceutical product is of major interest for public health and therapeutic innovation NEW YORK / Apr... Read more
Bristol Myers Squibb will utilize Cellares’ proprietary Cell Shuttle, a next-generation end-to-end, fully automated cell therapy manufacturing platform, for the clinical and commercial-scale manufacturing of select CAR T cell therapies
Cellares, the world’s first Integrated Development and Manufacturing Organization (IDMO), will allocate multiple Cell Shuttles and its fully automated, high-throughput Cell Q systems across its IDMO Smart Factories in the U.S., EU and... Read more
TOKYO, April 22, 2024 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK, President and CEO; Christophe Weber, "Takeda"), Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas"), and Sumitomo Mitsui Banking Corporation (President & CEO: Akihiro Fukutome, "SMBC") today announced that the three companies signed a master agreement on April 22, 2024, to establish a joint venture company. The new company will be dedicated to... Read more
Ipsen enters into an option agreement to receive exclusive global rights to two candidates pursued under the collaboration
Following development candidate validation, Ipsen will assume responsibility for further development and commercialization, leveraging existing neuroscience expertise in movement disorders
This promising platform technology created by Skyhawk allows for the exploration of previously undruggable RNA targets with small molecules, expanding the... Read more
NEW YORK, NY / ACCESSWIRE / April 19, 2024 / Sunshine Biopharma Inc. (NASDAQ:SBFM), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals, is happy to announce that its wholly owned generic pharmaceutical subsidiary, Nora Pharma, has received approval for its first Biosimilar product.
Nora Pharma has received approval from Health Canada for the commercialization of NIOPEG® (a pegylated... Read more
Approval is based on the Phase 3 KEYNOTE-859 Trial KIRKLAND, QC, April 19, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that Health Canada has granted approval of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing-chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric... Read more
ENTYVIO is Now Available in the U.S. in Both IV and Subcutaneous Administrations for Maintenance Treatment of Adults with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease OSAKA, Japan & CAMBRIDGE, Mass. / Apr 18, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved ENTYVIO® (vedolizumab) subcutaneous (SC) administration for maintenance therapy in adults with moderately... Read more
Approval based on Phase III ALINA study showing Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage resected non-small cell lung cancer (NSCLC)
This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy
The National Comprehensive Cancer Network® (NCCN®) Guidelines... Read more
TEL AVIV, Israel, April 18, 2024 (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 the closing of its previously announced public offering of an aggregate of 5,000,000 of the Company’s ordinary shares (or ordinary share equivalents) and warrants to purchase up to 5,000,000 ordinary shares at a combined... Read more
Results from the Phase 3 SELECT-GCA study showed 46 percent of patients with giant cell arteritis (GCA) who were treated with upadacitinib (RINVOQ®; 15 mg) with a 26-week steroid taper regimen achieved sustained remission from week 12 through week 52 compared to 29 percent of patients receiving placebo with a 52-week steroid taper regimen1
The safety profile in GCA was generally consistent with that in approved indications, and no new safety signals were identified... Read more
Collaboration leverages variant bio's cutting-edge genomic discovery platform and evotec's integrated end-to-end R&D platform and disease area expertise to address unmet medical need in fibrotic indications
Commercial terms include research funding and milestones and/or royalty payments to evotec based on the overall success of the program HAMBURG, Germany and SEATTLE, April 18, 2024 /PRNewswire/ -- Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX,... Read more
CAMBRIDGE, Mass. and NESS ZIONA, Israel, April 18, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the appointment of Susan Blum to its Board of Directors. Ms. Blum was also appointed to serve as a member and chair of the audit committee of the Board.
“We are pleased to welcome Susan Blum... Read more
The article published in Aesthetic Surgery Journal supports safety and duration of effect for temporary improvement in the appearance of moderate to severe glabellar lines presented at the 2023 ASDS Annual Meeting
Data showed duration effect of 26 weeks, or 6 months, based on a ≥ 1-point Glabellar Line Scale (GLS) improvement and return to baseline value using the Global Aesthetic Improvement Scale NEWPORT BEACH, Calif. / Apr 17, 2024 / Business Wire / Evolus, Inc.... Read more
Tirzepatide achieved a mean apnea-hypopnea index reduction of up to 63% (about 30 fewer events per hour), meeting all primary and key secondary endpoints in two phase 3 clinical trials
Tirzepatide meaningfully improved sleep apnea symptoms in those with moderate-to-severe OSA and obesity with and without PAP therapy, and based on these results Lilly plans to submit these data for global regulatory reviews INDIANAPOLIS, April 17, 2024 /PRNewswire/ -- Eli Lilly and... Read more
Results from the Phase III study showed that subcutaneous (SC) injection was consistent with IV infusion and demonstrated near-complete suppression of relapse activity (97%) and MRI lesions (97.2%) through 48 weeks
The twice-yearly, 10-minute SC injection has the potential to expand the usage of Ocrevus to treatment centers without IV infrastructure or with IV capacity limitations
U.S. FDA and EMA accepted filings based on the data from OCARINA II, with EU... Read more
HAMBURG, GERMANY / ACCESSWIRE / April 17, 2024 / Evotec SE (Frankfurt Stock Exchange:EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ:EVO) today announced the appointment of Aurélie Dalbiez as the Company's new Chief People Officer ("CPO"), effective 15 June 2024. Aurélie will be joining Evotec's Management Board, bringing with her a wealth of experience and expertise in Human Resources leadership.
In her role as CPO, Aurélie will oversee the development and implementation... Read more
Planning Underway for Phase 3 Development of Tezepelumab in COPD THOUSAND OAKS, Calif., April 16, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today provided an update regarding the results of the Phase 2a COURSE trial for TEZSPIRE® (tezepelumab-ekko) in chronic obstructive pulmonary disease (COPD), which were accepted for presentation in the Clinical Trials Symposium at The American Thoracic Society (ATS) 2024 International Conference on Monday, May 20, from 9:15-11:15... Read more
(Please see important safety information below)
NEW YORK, NY / ACCESSWIRE / April 16, 2024 / Petros Pharmaceuticals, Inc. ("Petros," or the "Company") (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces it has received positive feedback from the U.S. Food and Drug Administration (the "FDA," or the "Agency") following the FDA's informal review of Petros' technology component for... Read more
PALO ALTO, Calif., April 16, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today provided certain preliminary unaudited financial results for gross and net sales for ZTlido® for the quarter ended March 31, 2024, and proposed plans to reduce research... Read more
Almost 80% of patients with Huntington's disease (HD) chorea were able to achieve optimal dosing within four weeks with the 4-week Titration Kit in final START study results
START study results further support real-world effectiveness, safety, adherence and patient satisfaction with the 4-week Titration Kit for AUSTEDO
AUSTEDO remains the only vesicular monoamine transporter 2 (VMAT2) inhibitor available with 3-year data for this progressive condition1,2 TEL AVIV,... Read more
Novel 505(b)(2) presentation of a key injectable for treating non-squamous non-small cell lung cancer and malignant pleural mesothelioma, does not require reconstitution, dilution, or refrigeration
Amneal plans to launch two to three branded oncology 505(b)(2) products per year going forward – this is the first of 2024 BRIDGEWATER, N.J. / Apr 16, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced... Read more
