In Brief
Refine Search
Biotechnology
Today, Japanese pharma major Astellas announced the US Food and Drug Administration (FDA) has acknowledged the company’s resubmission of the Biologics License Application (BLA) for zolbetuximab. 31 May 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Teva Pharmaceutical's Austedo XR (deutetrabenazine), as a one pill, once-daily treatment option, now with four new tablet strengths (30, 36, 42, 48 mg) indicated in adults for tardive dyskinesia (TD) and Huntington’s disease (HD) chorea. 30 May 2024
Pharmaceutical
Helsinn and Angelini Pharma have renewed their distribution and licence agreement for Aulin (nimesulide) and Mesulid (nimesulide). 28 May 2024
Biotechnology
South Korea’s Ministry of Food and Drug Safety (MFDS) has approved the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) for treatment in adult patients with mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD (early AD). 28 May 2024
Pharmaceutical
Negotiators of a proposed World Health Organization (WHO) pandemic accord have been unable to reach consensus ahead of a self-imposed deadline of next week’s World Health Assembly. 25 May 2024
Pharmaceutical
Russia is experiencing a boom in demand and sales of antidepressants these days, according to recent statements by representatives of some leading local pharmacies and analysts. 21 May 2024
Pharmaceutical
A Delaware, USA, federal jury on Friday said that AstraZeneca should pay $107.5 million in royalty damages for infringing a Pfizer-brand cancer treatment patent, with its cancer drug Tagrisso (osimertinib), according to IP Law360. 20 May 2024
Biotechnology
USA-based Moderna has won a case at the European Patent Office (EPO) in its dispute with Pfizer and BioNTech over its Covid-19 vaccine, in a boost for the mRNA-vaccine maker in its ongoing legal fight to recoup pandemic profits from its rivals. 18 May 2024
Pharmaceutical
This week, the US Centers for Medicare & Medicaid Services (CMS) announced it would hold off on a provision to rule RIN 0938-AU28 that would have required pharmaceutical manufacturers to stack discounts and rebates to report a best price for the Medicaid drug rebate program. 17 May 2024
Biotechnology
While marking up 23 bills yesterday, the House Energy & Commerce Committee’s (E&C) Health Subcommittee approved H.R. 7384 to extend the PPRV program, which incentivizes R&D by giving vouchers to expedite review of pediatric rare disease drugs. 17 May 2024
Biotechnology
A Californian company working on allogeneic CAR T products has raised approximately $110 million through a stock offering. 16 May 2024
Pharmaceutical
Danish diabetes and obesity giant Novo Nordisk is planning to test whether its weight loss drugs, including semaglutide, marketed as Wegovy, can impact alcohol use in patients with liver disease, according to Bloomberg. 15 May 2024
Pharmaceutical
Japanese drugmaker Eisai today announced it has received approval in China for the additional indication of its in-house discovered antiepileptic drug (AED) Fycompa (perampanel hydrate) for adjunctive treatment of primary generalized tonic-clonic seizures in patients with epilepsy aged 12 years and older. 13 May 2024
Biotechnology
The US Food and Drug Administration (FDA) has notified Moderna that, due to administrative constraints, the agency does not expect to complete its review of the Biologics License Application (BLA) for mRNA-1345 by May 12. 10 May 2024
Biotechnology
Swiss company ADC Therapeutics has announced a $105 million underwritten offering of common shares and pre-funded warrants. 7 May 2024
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has now approved Pfizer’s Oxbryta (voxelotor) to be recommended for use on the National Health Service NHS to treat people with hemolytic anemia caused by sickle cell disease (SCD). 6 May 2024
Biotechnology
AstraZeneca on Monday announced the successful completion of an equity investment with France-based Cellectis, a clinical-stage biotechnology company. 6 May 2024
Pharmaceutical
Subsidies for Danish drugmaker giant Novo Nordisk’s diabetes drug Ozempic (semaglutide) will be restricted in its home country due to rising public spending on the blockbuster diabetes medicine, which is increasingly being used as a weight-loss treatment, according to a report from Bloomberg. 2 May 2024
Pharmaceutical
As of May 1, Johnson & Johnson is updating its brand and uniting both its two business segments under the Johnson & Johnson brand name in the UK. 1 May 2024
Generics
Danish specialty pharma company Xellia Pharmaceuticals, which is owned by Novo Holdings, today revealed that the US Court has vacated the Modified Consent Decree imposed on Xellia’s Cleveland, Ohio, USA facility in 2016. 29 April 2024
Biotechnology
US biotech major Amgen has announced that Dr Howard Chang will join the company as senior vice president of research, effective December 16, 2024. 21 November 2024
Biotechnology
US clinical-stage biotech Vyriad has entered into a strategic collaboration with Swiss pharma giant Novartis to discover and develop in vivo chimeric antigen receptor (CAR) T-cell therapies. 21 November 2024
Biotechnology
The European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab), from US pharma giant Pfizer. 20 November 2024
Biotechnology
Bioplatform company builder Flagship Pioneering has announced its companies Ampersand Biomedicines and Montai Therapeutics have entered into agreements to identify targeted molecules that could potentially be further developed as treatments for obesity and lung cancer. 20 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Biosimilars
Sweden-based Xbrane Biopharma and Intas Pharmaceuticals have announced an exclusive global licensing and co-development agreement for the former company’s Opdivo (nivolumab) biosimilar candidate. 20 November 2024
Biotechnology
A pair of industry veterans have teamed up to create Jupiter Bioventures, a San Francisco-based biotech venture foundry promised to build bold, science-driven therapeutics companies. 20 November 2024
Pharmaceutical
California, USA-based biotech Cytokinetics saw its shares fall as much as 4% to $9.67 yesterday, after it announced a deal with Germany’ Bayer. 20 November 2024
Pharmaceutical
Anthony Harnden has been appointed as the new chair of the UK’s Medicine and Healthcare products Regulatory Agency (MHRA). 20 November 2024
Biotechnology
The landscape of atopic dermatitis (AD) treatment is advancing with approvals of oral and topical Janus kinase (JAK) inhibitors across the seven major pharmaceutical markets (7MM; USA, France, Germany, Italy, Spain, UK and Japan). 20 November 2024
Biotechnology
Johnson & Johnson and partner Protagonist Therapeutics have reported positive topline results from two Phase III studies testing a first-in-class oral peptide. 20 November 2024
Biotechnology
The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) says that talks with the makers of Enhertu have ended without agreement, meaning guidance that does not recommend Enhertu for advanced breast cancer will remain unchanged. 20 November 2024
Biotechnology
Samsung Biologics, the biotech arm of Korea's Samsung Group, has announced a new manufacturing agreement worth $668 million. 20 November 2024
Biotechnology
Mirai Bio has announced the appointment of Jens Vogel as the company’s president and chief operating officer (COO). 20 November 2024
Pharmaceutical
Australia’s Therapeutic Goods Administration (TGA) yesterday warned that health professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under six years of age. 20 November 2024
Biotechnology
German biotech CatalYm has followed up a groundbreaking 2023 with an impressive 2024. 19 November 2024
Biotechnology
US pharma giant Merck & Co today announced positive top-line results from the pivotal Phase III MK-3475A-D77 trial for its mega blockbuster drug Keytruda (pembrolizumab) in subcutaneous form. 19 November 2024
Biotechnology
Aclaris Therapeutics has announced an exclusive licensing agreement with Biosion for broad rights to two new antibodies. 19 November 2024
Biotechnology
Privately-held US biotech Georgiamune has announced the appointment of Mark Avagliano as chief business officer (CBO). 19 November 2024
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze