Germany’s BioNTech, the company that has developed Comirnaty, the world’s most successful COVID-19 vaccine in partnership with Pfizer, has taken a next step to improve vaccine supply in Africa. 16 February 2022
Belgian life sciences investor Newton Biocapital has launched a new fund, NBC II, which will focus on supporting the growth and value creation in preclinical and clinical stage companies, to find solutions for chronic diseases. 15 February 2022
In 2021, the European Medicines Agency recommended 92 medicines for marketing authorization. Of these, 53 had a new active substance which had never been authorized in the European Union (EU) before. 15 February 2022
Indian drugmaker Dr Reddy's Laboratories entered into an exclusive sales and distribution agreement with Novartis India Limited (NIL) for the Voveran range, the Calcium range and Methergine in India. 14 February 2022
Pfizer and BioNTech SE plan to extend their rolling submission to the US Food and Drug Administration (seeking to amend the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine, also known as Comirnaty, to include children six months through four years of age, which had been requested by FDA. 12 February 2022
Life sciences and healthcare investment firm, LSP, has raised more than one billion euros ($1.14 billion) for its flagship fund, LSP 7. 11 February 2022
Asklepios BioPharmaceutical (AskBio) and Touchlight have restructured their joint venture, giving both parties co-exclusive rights to independently supply the adeno-associated virus (AAV) market with doggybone DNA. 8 February 2022
The year 2021 has set records for the Novo Nordisk Foundation and Novo Holdings, with research grants and investments in established companies scaling new heights at a total of 215 million euros ($246 million). 7 February 2022
Israel-based generics giant Teva Pharmaceutical Industries’ US subsidiary has reached an agreement with the Attorney General (AG) of Texas that settles the state’s and its subdivisions opioid-related claims. 7 February 2022
Australian stem cell therapy company Mesoblast has appointed Eric Rose, since 2013 a non-executive director, to the role of chief medical officer. 3 February 2022
Sweden-headquartered contract development and manufacturing organization Recipharm today announced the acquisition of GenIbet, a Portuguese CDMO, specializing in the manufacture of biological clinical trial material and novel modalities such as viral vectors, RNA and microbiome. 1 February 2022
The US Food and Drug Administration (FDA) has approved Cabenuva (cabotegravir/rilpivirine) for every-two-month dosing for the treatment of HIV-1 in virologically suppressed adults on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. 1 February 2022
The US Food and Drug Administration (FDA) has approved an update to the prescribing information for Yescarta (axicabtagene ciloleucel) to include use of prophylactic corticosteroids across all approved indications. 31 January 2022
The European Medicines Agency’s human medicines committee (CHMP) has recommended granting a conditional marketing authorization for US pharma giant Pfizer’s oral antiviral Paxlovid (PF-07321332/ritonavir) for the treatment of COVID-19. 27 January 2022
The European Commission has approved another indication for Merck & Co’s mega-blockbuster anti-PD-1 drug Keytruda (pembrolizumab), this time as monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC) at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. 27 January 2022
London-based Global Blood Therapeutics (GBT) has been given a positive scientific opinion under the UK’s Early Access to Medicines Scheme (EAMS), for its sickle cell disease candidate voxelotor. 27 January 2022
Trevi Therapeutics has announced significant milestones in its clinical programs for Haduvio (nalbuphine), an investigational therapy aimed at treating chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). 4 October 2024
Italian pharma major Recordati saw its shares rise more than 5% to 52.00 euros in early trading, as it announced a deal to expand its portfolio of marketed rare disease medicines. 4 October 2024
Paris-based asset manager Kurma Partners has raised 140 million euros ($154 million), successfully completing the first closing of Biofund IV 4 October 2024
The European Medicines Agency’s pharmacovigilance committee, PRAC, has started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviors. 4 October 2024
Opioid Use Disorder (OUD) is a chronic neurological disorder that is described as the consequences associated with repeated, compulsive use of opioid drugs and prolonged self-administration of opioid drugs. 4 October 2024
Proposals from the National Health Service (NHS) England have been set out for a phased launch of Eli Lilly’s obesity injection Mounjaro/Zepbound (tirzepatide) at the start of a consultation. 4 October 2024
Aspire Pharma, a UK-based niche generics business, has announced the acquisition of all assets from Canute Pharma, further expanding its product range. 4 October 2024
Bristol Myers Squibb has received a new approval from the US Food and Drug Administration for its blockbuster checkpoint blocker, Opdivo (nivolumab). 4 October 2024
Singapore’s Agency for Science, Technology and Research (A*STAR) and US biotech incubator Flagship Pioneering have agree to collaborate on advancing health and sustainability outcomes in Singapore and the broader Asia Pacific region. 4 October 2024
The US Food and Drug Administration (FDA) has removed the partial clinical hold on delpacibart etedesiran (del-desiran/AOC 1001), an investigational treatment designed to address the root cause of myotonic dystrophy type 1 (DM1), under development by US biotech Avidity Biosciences . 4 October 2024
F2G’s September $100m funding round provides the company with crucial funds to
renavigate approval of its lead drug, olorofim. The substantial financing also
highlights the paucity of novel antifungal products in the clinic. 3 October 2024
The US Food and Drug Administration (FDA) has granted the Gilead Sciences subsidiary Kite a Regenerative Medicine Advanced Therapy Designation (RMAT) for Yescarta (axicabtagene ciloleucel) for adults with newly-diagnosed, high-risk large B-cell lymphoma (LBCL). 3 October 2024
The US Food and Drug Administration (FDA) has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. 3 October 2024
Israel’s Teva Pharmaceutical Industries and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, have announced a global licensing deal for the development of an anti PD-1 oncology biosimilar candidate. 3 October 2024
Caliway Biopharmaceuticals has successfully completed its initial public offering, raising NT$6.4 billion ($206 million), the largest IPO in Taiwan's biotech industry to date. 3 October 2024
Kedrion Biopharma has finalized an agreement with Germany-based Biotest for the long-term commercialization and distribution of Yimmugo (immune globulin) in the USA. 3 October 2024
US clinical-stage biotech Arcus Biosciences has entered into a clinical trial collaboration with AstraZeneca on renal cancer treatments. 3 October 2024
PeptiDream says that its wholly-owned PDRadiopharma subsidiary has entered into a strategic partnership with French nuclear medicines firm Curium. 3 October 2024
Abivax ABVX) today announced the results of an interim efficacy and safety analysis of an open-label maintenance (OLM) study that enrolled patients with ulcerative colitis (UC). 3 October 2024