Drugs

BOSTON–(BUSINESS WIRE)–Jun. 9, 2021– Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children with cystic fibrosis (CF) ages 6 through 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a

The Phase III TULIP study met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement of its [Vic-]Trastuzumab Duocarmazine (SYD985) over physician’s choice, said the developer. PFS is defined as the time from the date of randomization to the date of first documented disease progression or death due to any cause, whichever

An application for the use of the vaccine in adolescents has already been submitted to Health Canada. In the EU, the mRNA vaccine is authorized for people aged 18+ (as is the case in the US and other markets), having been granted a Conditional Marketing Authorization in January. In May, Moderna published results from a

FDA Approves Prevnar 20 (pneumococcal 20-valent conjugate vaccine) for Adults Ages 18 Years or Older First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia,1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. Helps protect against more serotypes

FDA Grants Accelerated Approval for Aduhelm (aducanumab-avwa) for the Treatment of Alzheimer’s Disease CAMBRIDGE, Mass. and TOKYO, June 07, 2021 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Aduhelm™ (aducanumab-avwa) as the first and only Alzheimer’s

Unlike currently available therapies – which only treat symptoms of the diseases – Aduhelm is the first therapy to target and affect the underlying diseases process of Alzheimer’s, notes the FDA. “As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and

BOSTON–(BUSINESS WIRE)–Jun. 7, 2021– Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of Ultomiris (ravulizumab-cwvz) to include children (one month of age and older) and adolescents with paroxysmal nocturnal hemoglobinuria (PNH). Ultomiris, a long-acting C5 inhibitor that offers immediate, complete and sustained complement inhibition, is now the first and only

Novartis and Molecular Partners have announced the start of their EMPATHY Phase II/III study to explore the use of its DARPin (designed ankyrin repeat proteins) therapeutic candidate ensovibep (MP0420) for the treatment of COVID-19. Novartis reportedly will run the trial program, with Molecular Partners serving as sponsor. The EMPATHY clinical trial program is intended to

Bristol Myers Squibb (BMS) announced the US Food and Drug Administration (FDAP has approved Opdivo (nivolumab, injection for intravenous use) for adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT). The approval is based upon results from the recent Phase III

Leading the fundraising effort was Novalis Biotech Acceleration and Participatie Maatschappij Vlaanderen (PMV). “The Series A will enable us to complete our GMP compliant production line, which will go live by the end of 2021,”​ explained Prof Dr Thomas De Beer, RheaVita CEO. The company, established in 2018, would not disclose the total amount it

Mike Brewer, director, global principal consultant, regulatory, bioproduction, Thermo Fisher Scientific, spoke to BioPharma-Reporter about some of dos and don’ts on starter materials for CGT manufacturing. His advice is particularly targeted at newer entrants to the CGT space, those at the at the preclinical stage, that might not have the same level of regulatory expertise

Organon begins trading on the New York Stock Exchange (NYSE) under the ticker symbol, OGN, today. It is also starting out with a large commercial footprint consisting of a direct sales presence in 58 markets, and supply of products to over 140 countries. It outlined how it will be exploring new opportunities and partnerships across

FDA Approves Tembexa (brincidofovir) for the Treatment of Smallpox DURHAM, N.C., June 04, 2021 (GLOBE NEWSWIRE) — Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Tembexa (brincidofovir) tablets and oral suspension approval

FDA Approves Ryplazim (plasminogen, human-tvmh) for the Treatment of Plasminogen Deficiency Type 1 LAVAL, QC and CAMBRIDGE, England, June 4, 2021 /CNW Telbec/ – Liminal BioSciences Inc. (Nasdaq: LMNL) (“Liminal BioSciences” or the “Company”) announced today that the U.S. Food & Drug Administration (FDA) has approved Ryplazim (plasminogen, human-tvmh) (“Ryplazim”) for the treatment of patients

FDA Approves Wegovy (semaglutide) to Treat Adults with Obesity PLAINSBORO, N.J., June 4, 2021 /PRNewswire/ — Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for Wegovy™ (semaglutide) injection 2.4 mg, the first-and-only prescription weight-loss medication with once-weekly dosing. Wegovy™ is used with a reduced calorie meal plan and

Vaxxas’ COVID-19 vaccine is a recombinant SARS-CoV-2 spike glycoprotein, termed HexaPro, which has been stabilized in its prefusion conformation by removal of the furin cleavage site and the inclusion of six stabilizing proline mutations. According to the preclinical study, vaccination ‘induced enhanced T-cell and spike-specific antibody responses as compared to needle-and-syringe delivery of the same vaccine

Italy sees increase in biotech R&D investment The strong and dynamic synergies between universities, research centers, startups and large companies make the country a good location for biopharma investment, maintains the Italian Trade Agency (ITA) and other official entities. They cited a report by consultants, The European House – Ambrosetti, showing that between 2013 and

FDA Approves Brexafemme (ibrexafungerp) as the First and Only Oral Non-Azole Treatment for Vaginal Yeast Infections JERSEY CITY, N.J., June 02, 2021 (GLOBE NEWSWIRE) — Scynexis, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced that the U.S. Food and Drug Administration (FDA) has

While COVID-19’s grip on the globe seems to be gradually waning, organizers of pharma events are still judging on the side of caution and keeping most events virtual for the time being. However, virtual programs such as BIO Digital (scheduled online June 10-11 and June 14-18) still are promising real benefits for attendees. Theresa Brady,

In April, Biogen and Bio-Thera Solutions entered into a commercialization and license agreement to develop, manufacture and commercialize BAT1806, an anti-interleukin-6 (IL-6) receptor monoclonal antibody. Biogen gains exclusive regulatory, manufacturing and commercial rights to BAT1806 in all countries excluding China (including Hong Kong, Macau and Taiwan), allowing the Cambridge, Massachusetts company to expand its global

FORT LEE, N.J. and REHOVOT, Israel, June 02, 2021 (GLOBE NEWSWIRE) — Kedrion Biopharma and Kamada Ltd. (NASDAQ & TASE: KMDA), two leading biopharmaceutical companies specialized in plasma-derived protein therapeutics, announced today the U.S. Food and Drug Administration (FDA) has approved a label update for KedRAB® (Rabies Immune Globulin [Human]), establishingthe product’s safety and effectiveness

FDA Approves Lybalvi (olanzapine and samidorphan) for the Treatment of Schizophrenia and Bipolar I Disorder DUBLIN, June 1, 2021 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved Lybalvi (olanzapine and samidorphan) for the treatment of adults with schizophrenia and for the treatment of adults with