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Biotechnology
The US Food and Drug Administration (FDA) has accepted Eisai’s supplemental Biologics License Application (sBLA) for monthly Leqembi (lecanemab-irmb) intravenous (IV) maintenance dosing. 10 June 2024
Biotechnology
The European Medicines Agency (EMA) has approved a Type II variation to the Summary of Product Characteristics (SmPC) for its approved Chimeric Antigen Receptor (CAR) T-cell therapies, Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) from Gilead Sciences’ Kite subsidiary. 6 June 2024
Biotechnology
Netherlands-based gene therapy company uniQure announced that the US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for its AMT-130 gene therapy in development for Huntington’s disease. 3 June 2024
Pharmaceutical
German family-owned pharma major Boehringer Ingelheim’s new program to cap out-of-pocket costs at $35 per month for eligible patients for the company’s inhalers is now available. 1 June 2024
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
Pharmaceutical
In Latin America, the average percentage of the public budget for health is 12.75%, half of what is allocated by the 38 countries that make up the Organization for Economic Cooperation and Development (OECD), which on average is 24.5%. 6 June 2025
Pharmaceutical
US cardiorenal-focussed drugmaker Ardelyx announced that Mike Kelliher, formerly executive vice president, corporate development and strategy, has been promoted to chief business officer, and James Brady has joined the company as chief human resources officer. 6 June 2025
Biotechnology
Sweden’s Sobi and US biopharma Apellis Pharmaceuticals have presented new data from the open-label period of the Phase III VALIANT study, investigating Aspaveli/Empaveli (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). 6 June 2025
Biotechnology
Japan’s Otsuka today presented positive results from a pre-specified interim analysis of the Phase III VISIONARY study (NCT05248646) evaluating sibeprenlimab, for the treatment of immunoglobulin A nephropathy (IgAN) in adults. 6 June 2025
Biotechnology
China-based Kelun-Biotech Biopharmaceutical announced the placement of 5,918,000 H shares under its general mandate, representing approximately 2.54% of the enlarged share capital of the company post the placement. The shares were placed at HK$331.8 per share, raising net proceeds of around US$250 million. 6 June 2025
Biotechnology
The dynamics of the Friedreich's ataxia market are anticipated to change as companies across the globe work towards the development of new drug therapy options to treat this disease, according to a report from DelveInsight. 6 June 2025
Biotechnology
Texas-based ImmunoPrecise Antibodies, a leader in AI-driven biotherapeutics, closed 22% higher Thursday. 6 June 2025
Pharmaceutical
US biotech Trevi Therapeutics has raised around $115 million in a public stock offering, giving it fresh momentum to continue developing its investigational therapy Haduvio (nalbuphine) for chronic cough. 6 June 2025
Biotechnology
Genetic testing company 23andMe is preparing for a renewed auction of its assets after a federal judge agreed to reopen the sale process, following an eleventh hour bid from company co-founder Anne Wojcicki. 6 June 2025
Pharmaceutical
AstraZeneca has received European approval for a fixed-duration regimen of Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, for adults newly diagnosed with chronic lymphocytic leukemia (CLL). 6 June 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the use of German pharma major Bayer’s Nubeqa (darolutamide) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT). 6 June 2025
Biotechnology
US commercial-stage drugmaker Corcept Therapeutics has presented results from its DAZALS study of dazucorilant in patients with amyotrophic lateral sclerosis (ALS) at the European Network to Cure ALS (ENCALS) 2025 annual meeting. 6 June 2025
Biotechnology
US gene therapy company RegeNXBio yesterday announced new positive interim data from the Phase I/II AFFINITY DUCHENNE trial. Updates include positive functional, safety and biomarker data for RGX-202, RegeNXBio’s potential best-in-class, investigational gene therapy for Duchenne muscular dystrophy. 6 June 2025
Biotechnology
The New Drug Application (NDA) for the combination of fruquintinib and sintilimab for locally advanced or metastatic renal cell carcinoma patients who have failed prior treatment with one tyrosine kinase inhibitor (TKI) has been accepted for review by the China National Medical Products Administration (NMPA). 5 June 2025
Biotechnology
San Jose, USA-based biotech Allay Therapeutics today announced the completion of a $57.5 million Series D financing round with leading global investors. 5 June 2025
Biotechnology
German genetic medicine company ViGeneron has announced a rebrand to become VeonGen Therapeutics. 5 June 2025
Biotechnology
US rare disease meds developer Sarepta Therapeutics revealed that its rAAVrh74 viral vector used in the investigational gene therapy SRP-9003 (bidridistrogene xeboparvovec) for the treatment of limb-girdle muscular dystrophy type 2E/R4, has been granted platform technology designation by the US Food and Drug Administration. 5 June 2025
Biotechnology
AI-enabled biotech Juvenescence today announced the acquisition of Ro5 Inc, a proprietary AI drug discovery company. 5 June 2025
Biotechnology
US biopharma Cullinan Therapeutics has entered into an agreement with Genrix Bio for an all-indication, exclusive license to velinotamig, a BCMAxCD3 bispecific T-cell engager for everywhere outside Greater China. 5 June 2025
Pharmaceutical
China’s National Medical Products Administration approved its first domestically-developed nine-valent human papillomavirus (HPV) vaccine on Thursday. 5 June 2025
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