US health technology assessor The Institute for Clinical and Economic Review (ICER) has posted a Draft Scoping Document outlining a planned review of the comparative clinical effectiveness and value treatments for beta thalassemia. 7 January 2020
Biocon Biologics India, a subsidiary of India’s Biocon, has received an equity investment from True North worth around $75 million, subject to standard closing conditions. 6 January 2020
Austria-based Hookipa Pharma says that it has made strong progress in its collaboration with Gilead Sciences for new arenavirus-based therapeutics intended to support functional cures for chronic hepatitis B virus (HBV) and human immunodeficiency virus (HIV) infections. 6 January 2020
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the use of Dysport (clostridium botulinum type A toxin-haemagglutinin complex) for the symptomatic treatment of focal spasticity of upper limbs in pediatric cerebral palsy patients, two years of age and older. 6 January 2020
Japan’s Eisai has launched Fycompa (perampanel) in China, for use in the adjunctive treatment of certain people with partial-onset seizures. The therapy was approved by the Chinese regulator in mid October. 6 January 2020
US health technology assessor The Institute for Clinical and Economic Review ICER) announced on Friday that it plans to assess the comparative clinical effectiveness and value of valoctocogene roxaparvovec for the treatment of hemophilia. 4 January 2020
Aridis Pharmaceuticals, a US biotech focused on the discovery and development of targeted immunotherapies using fully human monoclonal antibodies (MAbs) to treat life-threatening bacterial infections, today announced the appointment of Michael Nazak as its chief financial officer (CFO) effective January 1, 2020. 2 January 2020
The drug price hike of 2020 has commenced, with costs rising for more than 250 medications, according to data analyzed by 3 Axis Advisors and reported by Reuters. 2 January 2020
The New Drug Application (NDA) for China's first human papillomavirus (HPV) vaccine has received approval from the National Medical Products Administration (NMPA). 1 January 2020
Theravance Biopharma and US pharma giant Pfizer have entered into a global license agreement for the former’s preclinical program for skin-targeted, locally-acting pan-Janus kinase (JAK) inhibitors that can be rapidly metabolized.
December 24, 2019 27 December 2019
Adding to a previous deal on dermatological products, Swedish firm Karo Pharma has now acquired a focused intimate care and dermatology product portfolio from privately-held Danish firm LEO Pharma for 90 million euros ($99.8 million). 27 December 2019
China's National Medical Products Administration (NMPA) has issued a bioequivalence comparison guideline for Chinese generic vaccine manufacturers. 24 December 2019
AstraZeneca’s triple-combination therapy, budesonide/glycopyrronium/formoterol fumarate (BGF), has been approved in China as a maintenance treatment for chronic obstructive pulmonary disease (COPD). 23 December 2019
US pharma giant Merck, known as MSD outside the USA and Canada, yesterday announced that Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, received new approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA) in advanced renal cell carcinoma (RCC) and head and neck cancer for the following additional indications in Japan: 21 December 2019
US healthcare giant Johnson & Johnson yesterday announced the acquisition of TARIS Biomedical, a privately-owned US biotechnology company specializing in the development of a novel drug delivery technology for the treatment of bladder diseases including cancer. 21 December 2019
The US Food and Drug Administration is warning that serious breathing difficulties may occur in patients using gabapentin (Neurontin, from Pfizer, Gralise, from Depomed, Horizant, from XenoPort) or pregabalin (Lyrica, Lyrica CR, both from Pfizer) who have respiratory risk factors. 20 December 2019
Swedish life science group Aqilion has decided to shut down its Trophea companies, which have been working on the development of a topical gel for skin atrophy. 20 December 2019
Japanese drugmaker Daiichi Sankyo has launched a biosimilar product in its home country referencing the Roche cancer drug Avastin (bevacizumab). 19 December 2019
The University of Virginia (UVA) Center for Diabetes Technology and Denmark’s Novo Nordisk today announced that they have entered into a five-year research collaboration where UVA and Novo Nordisk will work together on the development of virtual environments focused on modelling of patients with type 2 diabetes. 19 December 2019
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