US pharma major AbbVie says that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Rinvoq (upadacitinib), an oral JAK inhibitor, for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. 1 September 2021
The US District Court for the District of Delaware has held that Eagle Pharmaceuticals’ proposed vasopressin product does not infringe any of the patents that Par Pharmaceutical had claimed that it did. 1 September 2021
China is about to approve the country's first biosimilar of Amgen's Xgeva (denosumab), which is indicated for the prevention of skeletal-related events in people with bone metastases from solid tumors and in patients with multiple myeloma. 1 September 2021
The US Food and Drug Administration (FDA) has approved an expanded indication for Briviact (brivaracetam) CV tablets, oral solution, and injection to treat partial-onset seizures in patients as young as one month old. 31 August 2021
Japanese drugmaker Otsuka Pharmaceutical has announced that Ajovy (fremanezumab) subcutaneous injection 225mg Syringe was launched in Japan for the indication of preventive treatment of migraine in adult patients on August 30. 31 August 2021
China's National Medical Products Administration (NMPA) has granted approval for the New Drug Application (NDA) for the new anti-PD1 monoclonal antibody (MAb) – zimberelimab, from Harbin Gloria Pharmaceutical and WuXi Biologics, as a second line treatment for recurrent/refractory classical Hodgkin's lymphoma (CHL). 30 August 2021
The UK’s National Institute for Health and Care Excellence (NICE) has published draft guidance recommending against National Health Service provision of Darzalex (daratumumab) in a specific indication. 27 August 2021
In its weekly newsletter, the USA’s Institute for Clinical and Economic Review (ICER) noted that, on July 9, the Biden administration directed Health and Human Services (HHS) Secretary Xavier Becerra to develop a “comprehensive” plan on drug pricing reform within 45 days -- a deadline that came and went earlier this week. 27 August 2021
India’s Lupin has launched Luforbec (beclometasone/formoterol) in the UK, making it the first branded generic alternative to Chiesi’s Fostair. This follows the granting of regulatory approval earlier this year. 25 August 2021
Japanese drugmaker Otsuka Pharmaceutical today announces it has received regulatory approval in Japan for a once-daily form in pediatric patients of Busulfex (busulfan) Injection 60mg. 25 August 2021
The European Commission (EC) has approved US pharma giant Pfizer’s Xeljanz (tofacitinib) for the treatment of active polyarticular juvenile idiopathic arthritis (JIA) and juvenile psoriatic arthritis (PsA) in patients two years of age and older who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (DMARDs). 21 August 2021
Bristol Myers Squibb stalwart Scott Cooke has been named the company’s general manager for the UK and Ireland, replacing Lynelle Hoch who has been promoted into a new role at the group’s corporate headquarters in the USA. 18 August 2021
Just eight months after launching with a $50 million Series A, Cambridge, USA-based Vigil Neuroscience has announced a $90 million Series B financing led by Vida Ventures to further advance its pipeline of microglia targeted medicines for the treatment neurodegenerative diseases. 18 August 2021
An extension to the current UK approval of the Spikevax vaccine (formerly COVID-19 Vaccine Moderna) from US mRNA-based biotech Moderna, that allows its use in 12- to 17-year-olds has today been authorized by the Medicines and Healthcare products Regulatory Agency (MHRA). 18 August 2021
Following a public consultation, the UK’s Medicine and Healthcare products Regulatory Agency (MHRA) is making Nuromol, which ontains 200mg of ibuprofen and 500mg of paracetamol per tablet, available as a General Sales medicine, meaning it can be bought without the need to visit a pharmacy. 17 August 2021
UK biotech Freeline Therapeutics, which is developing transformative AAV-mediated gene therapies for patients suffering from inherited systemic debilitating diseases, today announced the appointment of Michael Parini as chief executive and executive director of the company. 16 August 2021
The Brazilian research institute Fiocruz has announced the signing of an agreement with the regional government and State University of Ceará for the development and production of the HH-120-Defenser vaccine against COVID-19. 16 August 2021
US trade group the Association for Accessible Medicines has appointed Joe Russo as senior director, federal government affairs, in order to help develop the association’s strategy and implement the initiatives of AAM’s government affairs department. 13 August 2021
Heraeus Pharmaceutical Ingredients’ additional production line for platinum-based highly potent active pharmaceutical ingredients (Pt hAPIs) is now fully operational at the company’s headquarters in Hanau, Germany. 10 August 2021
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