SILVER SPRING, Md., July 28, 2021 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be
Drugs
The pharmaceutical giant’s Q2 revenues reached $19bn, reflecting 86% operational growth thanks to the COVID-19 vaccine which contributed $7.8bn in direct sales and alliance revenues. Excluding the COVID-19 vaccine, revenues grew 10% to $11.1bn. 2.1 billion doses now on order for 2021 Pfizer’s earlier revenue estimates of $26bn for the COVID-19 vaccine was based on
The investment will include the doubling of capacity in multiple site locations as well as two new sites: one in the UK and one in the US. This is the largest investment in capacity to date for Pall and Cytiva, following five acquisitions made by the companies this year and an additional US$500m in previously-announced
faricimab Treatment for Wet Age-Related Macular Degeneration (AMD); Diabetic Macular Edema (DME) FDA Accepts Application for Genentech’s Faricimab for the Treatment of Wet Age-Related Macular Degeneration (AMD) and Diabetic Macular Edema (DME) South San Francisco, CA — July 28, 2021 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced
oteseconazole Treatment for Vaginal Candidiasis Mycovia Pharmaceuticals Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis DURHAM, N.C.–(BUSINESS WIRE) July 28, 2021 –Mycovia Pharmaceuticals, Inc. (Mycovia), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel
FDA Approves Twyneo (tretinoin and benzoyl peroxide) for the Treatment of Acne Vulgaris NESS ZIONA, Israel, July 27, 2021 (GLOBE NEWSWIRE) — Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced that the Food and Drug
The all-stock asset acquisition is valued at $58.7m. AC Immune – a Swiss biopharmaceutical company working on precision medicine for neurodegenerative diseases – says the acquisition will make it ‘a leader in the development of therapeutics and diagnostics for Parkinson’s disease’. It will immediately launch a Phase 2 study for the newly acquired vaccine candidate.
As a global provider of life science antibodies and reagents, privately-held BioLegend has more than 700 employees (primarily in the US) with estimated 2022 revenues of $380m and a manufacturing facility in San Diego, California. Itprovides academic and biopharmaceutical customers with antibodies and reagents in high-growth areas such as cytometry, proteogenomics, multiplex assays, recombinant proteins,
KENILWORTH, N.J.–(BUSINESS WIRE) July 27, 2021 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and
sulopenem Treatment for Bacterial Infection Iterum Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Oral Sulopenem DUBLIN, Ireland and CHICAGO, July 26, 2021 (GLOBE NEWSWIRE) — Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by
A clearer picture of how supply deals are shaping up could emerge later this week as Pfizer releases its Q2 2021 results. At last count in mid-April, Pfizer and BioNTech had 1.6 billion doses of its mRNA vaccine on order for 2021, but acknowledged the figure could rise as more deals were put in place.
News FDA Alerts HIS Issues Voluntary Nationwide Recall of Miss Slim Due to the Presence of Undeclared Sibutramine July 22, 2021 Audience: Consumer July 22, 2021 — Palisades Park, NJ, HIS is voluntarily recalling all lots and all presentations of Miss Slim (10 count & 30 count capsules) to the consumer level. HIS decided to
Philadelphia, London — 26 July 2021 — GlaxoSmithKline plc today announced that the US Food and Drug Administration (FDA) has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 18 years and older who are or who will be at increased risk of shingles due to immunodeficiency or
News New Drug Applications FDA Accepts Braeburn’s New Drug Application Resubmission for Brixadi (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder Treatment for Opiate Dependence FDA Accepts Braeburn’s New Drug Application Resubmission for Brixadi (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder Plymouth Meeting, Pa. – June 26, 2021
The $39bn deal, announced in December 2020, is AstraZeneca’s largest ever acquisition: allowing it to move further into immunology with an enhanced scientific presence, and giving it Alexion’s lead medicine soliris (eculizumab), among four other approved medicines and a pipeline of 11 molecules. AstraZeneca predicts Alexion will deliver double-digit average annual revenue growth through 2025:
The COVID-19 pandemic saw greater flexibility in the regulatory approach to prevent drug shortages. Some commentators have asked whether the agency’s new experience with and comfort from exercise of its emergency use authorization (EUA) authority during the coronavirus crisis was a factor in the recent accelerated approval of Biogen’s Alzheimer’s drug, a move that attracted
The drug is branded as Skysona. The approval is restricted to patients less than 18 years old with an ABCD1 genetic mutation. The one-time gene therapy is targeted at patients who do not have a matched sibling donor for hematopoietic stem cell (HSC) transplant. The marketing authorization is supported by efficacy and safety data from
WILMINGTON, Del.–(BUSINESS WIRE) July 23, 2021–AstraZeneca’s Bydureon BCise (exenatide extended-release), once-weekly injectable suspension has been approved in the US for the treatment of type 2 diabetes (T2D); to improve glycemic control in pediatric patients (10 to 17 years) as an adjunct to diet and exercise. The approval by the US Food and Drug Administration (FDA)
NORTH CHICAGO, Ill., July 23, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved Dalvance® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. Dalvance is the first single-dose option administered as a 30-minute intravenous (IV) infusion for
July 19, 2021 Audience: Consumer Tucson, AZ, Alpha Male Plus is voluntarily recalling all lots within expiry of Alpha Male Plus Male Enhancer fruit chews to the consumer level. FDA analysis has found the product to be tainted with tadalafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in a FDA approved product for
The plant, equipped with 2D/3D bioreactors, will enhance its existing stem cell research and repository capabilities with mesenchymal stem cell (MSC) biologics manufacturing, said the company. Generate said the site will allow it to add the role of therapeutics developer with in-house manufacturing capabilities to its core international donor gamete, genetics service and newborn stem
Thanks to Biovac’s manufacturing facilities in Cape Town, the deal will add a third continent to the mRNA vaccine’s supply chain and manufacturing network (with production to date having taken place in North America and Europe). Technical transfer, on-site development and equipment installation will begin at the site immediately. This will allow the facility to
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