In Brief
Refine Search
Biotechnology
Via its local subsidiary, Germany’s BioNTech has agreed to acquire Novartis’ (NOVN: VX) GMP-certified manufacturing facilities in Singapore. 14 November 2022
Biotechnology
The US Food and Drug Administration (FDA) has approved Adcetris (brentuximab vedotin) for the treatment of pediatric patients two years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide. 11 November 2022
Biotechnology
Bristol Myers Squibb has opened its Cruiserath Biologics site in Dublin, Ireland, 125-acre facility with approval from US and EU regulators, costing $1 billion to develop. 11 November 2022
Biotechnology
UK pharma major AstraZeneca says its rare diseases business Alexion is expanding its presence in Asia, announcing the availability in China of Soliris (eculizumab). 11 November 2022
Pharmaceutical
In a draft decision, the UK’s reimbursement agency has opted not to recommend funding for Lynparza (olaparib) for women with early-stage, high-risk breast cancer. 10 November 2022
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Cosentyx (secukinumab), alone or in combination with methotrexate (MTX), in two types of juvenile idiopathic arthritis (JIA). 9 November 2022
Pharmaceutical
Shanghai Yingli Pharmaceutical announced that linperlisib, trade name因他瑞®, a novel phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, has been approved by the National Medical Products Administration (NMPA) of China for the treatment of relapsed/refractory follicular lymphoma (R/R FL) in patients who have received two or more prior systemic therapies. 9 November 2022
Biotechnology
Merck & Co’s 15-strain Streptococcus vaccine, Vaxneuvance, has won UK approval for use in infants as young as six months, adding to the existing nod for adults. 9 November 2022
Pharmaceutical
With the aim of strengthening its presence in these markets and its leadership in Europe in medical dermatology, Spain’s leading drugmaker Almirall has opened new affiliates in the Czech Republic and Slovakia. 8 November 2022
Pharmaceutical
UK-based Ubiquigent, a drug discovery and development company harnessing novel deubiquitinase (DUB) modulators as new therapeutics for areas of high unmet medical need, has named Hozefa Amijee as head of business development (BD). 7 November 2022
Pharmaceutical
US clinical-stage biopharma firm Rivus Pharmaceuticals has presented positive top-line results from a Phase IIa trial evaluating the safety and efficacy of HU6, a first-in-class controlled metabolic accelerator (CMA), to address liver fat and total body fat in patients with non-alcoholic fatty liver disease (NAFLD). 7 November 2022
Pharmaceutical
British immunotherapy specialist Scancell has in-licensed the SNAPvax technology from Vaccitech, enabling it to formulate and manufacture Modi-2. 7 November 2022
Pharmaceutical
British pharma major AstraZeneca has appointed Stefan Woxström as senior VP of Europe and Canada, replacing Iskra Reic, who becomes executive VP of vaccines and immune therapies. 7 November 2022
Biotechnology
Italian contract development and manufacturing organization (CDMO) ReiThera is set to open a new viral vector production area at its facility in Italy. 3 November 2022
Pharmaceutical
Exelixis and Cybrexa Therapeutics have entered into an exclusive collaboration agreement, giving the former the right to buy a first-in-class peptide-drug conjugate (PDC). 2 November 2022
Biotechnology
US pharma major Eli Lilly has submitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for lebrikizumab, an investigational interleukin (IL)-13 inhibitor for the treatment of moderate-to-severe atopic dermatitis (AD). 2 November 2022
Biotechnology
A new pilot program has been announced by the US Food and Drug Administration, aimed at facilitating readiness for certain products with accelerated clinical development timelines. 1 November 2022
Pharmaceutical
China has banned UK pharma major GSK's Avodart (dutasteride) being sold in the country, effective from October 31,2022 to April 29, 2024. 1 November 2022
Pharmaceutical
Terumo Corp’s Terumo Pharmaceutical Solutions (TPS) unit intends to expand its contract development and manufacturing services for parenteral drugs to global customers. 1 November 2022
Pharmaceutical
The European Medicines Agency is to proceed with its review of a submission for a novel drug, vamorolone, for the treatment of Duchenne muscular dystrophy (DMD). 31 October 2022
Biotechnology
Privately-held US biotech Alloy Therapeutics has announced a strategic collaboration and license agreement with Takeda Pharmaceutical. 21 November 2024
Pharmaceutical
Japanese drugmaker Eisai has announced that the amyotrophic lateral sclerosis (ALS) treatment Rozebalamin for Injection (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis. 21 November 2024
Pharmaceutical
Germany's Merck has spent more than 25 years researching and developing solutions for advancing multiple sclerosis (MS) care. 21 November 2024
Biotechnology
San Diego-based Cidara Therapeutics, a biotech using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, has entered into a securities purchase agreement with certain investors to raise up to around $105 million. 21 November 2024
Pharmaceutical
Swiss pharma giant Novartis today announced an upgrade to its mid-term guidance, in advance of its Meet Novartis Management event for investors and analysts in London. 21 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 2024
Biotechnology
Eli Lilly is not resting on its laurels when it comes to the fast-growing field of obesity treatments, an area in which it is already a leader. 21 November 2024
Biotechnology
Aizen Therapeutics, an AI-driven biotech headquartered in San Diego, has officially launched from stealth mode, introducing its drug discovery platform, DaX. 21 November 2024
Biotechnology
San Diego-based Valora Therapeutics, a biotech that boasts of having a novel approach to immunotherapy, has announced the successful closing of a $30 million seed funding round. 21 November 2024
Biotechnology
Astellas Pharma has been hit by bad news from the US Food and Drug Administration, which will not currently approve the firm’s request to supplement the label for Izervay (avacincaptad pegol). 21 November 2024
article
The UK government has reappointed BioIndustry Association (BIA) chairman Daniel Mahony as its Life Sciences Investment Envoy. 21 November 2024
Pharmaceutical
Sage Therapeutics will down tools on its dalzanemdor program, after the Phase II DIMENSION trial missed both primary and secondary endpoints. 21 November 2024
Biotechnology
San Diego-based Kura Oncology and Japan’s Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib. 21 November 2024
Biotechnology
HCW Biologics has announced a worldwide licensing agreement with WY Biotech to develop and commercialize one of its preclinical immunotherapy candidates. 21 November 2024
Pharmaceutical
Shanghai-based Leading Tac Pharmaceutical has announced the successful completion of a series A financing round, raising over 100 million yuan ($14 million). 21 November 2024
Biotechnology
Dutch clinical-stage biotech NewAmsterdam Pharma, which is focused on non-statin medicines for patients at risk of cardiovascular disease (CVD), has announced positive top-line data from its Phase III TANDEM clinical trial. 21 November 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
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