The US Food and Drug Administration (FDA) has extended its review of the Supplemental Biologics License Application (sBLA) for ofatumumab (OMB 157), Novartis’ self-administered, targeted B-cell therapy for relapsing multiple sclerosis. 3 June 2020
Rare disease specialist Amryt has inked a distribution agreement for Myalepta (metreleptin) with Baar, Switzerland-based firm Swixx BioPharma. 3 June 2020
Bristol-Myers Squibb has announced the US launch of Zeposia (ozanimod) 0.92 mg, a new once-daily oral medication to treat relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. 1 June 2020
Sanofi has named four new leaders to its Executive Committee, completing previously announced changes to further simplify the company’s leadership team. 29 May 2020
UK gene and cell therapy group Oxford Biomedica closed up 6.6% at 764 pence today, having hit a high of 795 pence, after it revealed it has signed a one year clinical a commercial supply agreement with AstraZeneca. 28 May 2020
Lyon, France-based MaaT Pharma has appointed Savita Bernal as chief business officer, replacing Jean-Marc Renard, who will continue to advise the company. 28 May 2020
China's medicines regulator the Center for Drug Evaluation (CDE) re-opened its office on Monday, after months-long lockdown during the COVID-19 pandemic. 26 May 2020
Mitsubishi Tanabe Pharma (MTPC) today announced that its subsidiary in Thailand has obtained regulatory approval for Tenelia (teneligliptin hydrobromide hydrate) 20mg tablets for a treatment agent for type 2 diabetes mellitus from the country’s Food and Drug Administration, following the completion of the approval application procedure. 25 May 2020
In a letter to World Health Organization (WHO) director general Tedros Adhanom Ghebreyesus, US President Donald Trump, who last month suspended US funding to the agency, threatened to make this temporary freeze permanent and reconsider the USA’s membership altogether. 19 May 2020
More than 50 independent pharmacies have filed a class action lawsuit against OptumRx, a division of UnitedHealth Group, alleging that the company failed to comply with state pharmacy claims reimbursement law. 15 May 2020
US biotech Halozyme Therapeutics says that it will receive a $15 million milestone payment from Janssen Biotech, a pharma unit of Johnson & Johnson, triggered under the collaboration and license deal between the two companies. 15 May 2020
China on May 12 initiated bio-equivalence testing for generic injectables, including those are already in the market as well as those that have not filed a New Drug Application (NDA) according to the National Medical Products Administration (NMPA). 15 May 2020
Gene therapy specialist Spirovant Sciences has appointed Roland Kolbeck, former MedImmune head of respiratory, inflammation and autoimmune research, as chief scientific officer. 13 May 2020
Indian drugmaker Glenmark Pharmaceuticals today announced the launch of a single inhaler Triple Therapy AIRZ-FF, a combination of two bronchodilators, glycopyrronium and formoterol and the inhalation corticosteroid fluticasone propionate, for chronic obstructive pulmonary disease (COPD). 11 May 2020
Swiss drugmaker Roche has appointed Aviv Regev as the new Head of Genentech Research and Early Development (gRED), replacing Michael Varney, who is retiring. 11 May 2020
US pharma major AbbVie has finally completed its $63 billion acquisition of Ireland-incorporated Allergan, following receipt of regulatory approval from all government authorities required by the transaction agreement and approval by the Irish High Court. 9 May 2020
GlaxoSmithKline has completed divestment of its Horlicks and other Consumer Healthcare nutrition products in India to Unilever, raising about £3.4 billion ($4.2 billion). 7 May 2020
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