US drugmaker AbbVie has announced positive topline results from its pivotal Phase III TEMPO-1 trial for tavapadon as a monotherapy in early Parkinson's disease. 26 September 2024
Evaxion Biotech has entered into an option and license agreement with MSD (tradename of Merck & Co outside of the USA and Canada), for two pre-clinical vaccine candidates. 26 September 2024
Danish CNS specialist Lundbeck and US privately-held biotech Iambic Therapeutics today announced a strategic research collaboration to focus on discovery of a small molecule therapeutic for the treatment of migraine. 26 September 2024
The generics and biosimilars trade group, Medicines for Europe, has put out a strong message amid ongoing discussions on a European Union (EU) Critical Medicines Act. 26 September 2024
Pfizer (NYSE: PFE) has announced the withdrawal of Oxbryta (voxelotor), a treatment for sickle cell disease (SCD), from all global markets. 26 September 2024
US biotech major Amgen rolled out senior executives and a swish presentation in providing an update on two of its drugs in Phase III trials this week. 26 September 2024
US biotech Emergent BioSolutions revealed it has secured approximately $400 million in orders in 2024 and 2025 associated with its vaccinia, smallpox and mpox product portfolio. 26 September 2024
German drug discovery company Evotec has entered a technology development partnership with Danish drugmaker Novo Nordisk in cell therapy. 26 September 2024
Recently-created by US biotech incubator Flagship Pioneering, Abiologics has announced the appointment of Maria-Chiara Magnone as its chief scientific officer. 26 September 2024
LEO Pharma has presented late-breaking data on the DELTA FORCE trial for Anzupgo (delgocitinib) cream as a potential treatment for adult patients with moderate to severe chronic hand eczema (CHE). 26 September 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Joenja (leniolisib), from Netherlands-based Pharming. 26 September 2024
The UK government has released a position paper outlining its vision for Framework Programme 10 (FP10), a successor to Horizon Europe, the EU's flagship research collaboration program. 26 September 2024
Shanghai-based Junshi Biosciences has announced that the European Commission has approved Loqtorzi (toripalimab) for two cancer indications. 26 September 2024
Asklepios BioPharmaceutical (AskBio), a gene therapy company wholly-owned and independently operated as a subsidiary of Bayer, has announced a new strategic collaboration with Belief BioMed (BBM) to explore the potential for new gene therapies. 25 September 2024
Italian biotech Genespire—which is developing off-the-shelf gene therapies for pediatric patients affected by genetic diseases—has announced the closing of a 46.6 million euros ($52 million) Series B financing. 25 September 2024
US biotech 2seventy bio and partner Bristol Myers Squibb today revealed that they will discontinue enrollment in its ongoing Phase III KarMMa-9 study. 25 September 2024
Amgen yesterday revealed that Tepezza (teprotumumab [genetical recombination]) has been approved for the treatment of active or high clinical activity score (CAS) thyroid eye disease (TED) in Japan. 25 September 2024
Eli Lilly's Kisunla has been approved in Japan for early symptomatic Alzheimer's disease, following its US approval in July 2024. Administered via IV infusion, it targets patients with mild cognitive impairment and dementia linked to amyloid pathology. Kisunla aims to slow cognitive and functional decline in AD patients 25 September 2024
VBI Vaccines shares were up 10.4% at $1.75 by midday on Tuesday, after it announced commercial availability of PreHevbrio, the only Food and Drug Administration-approved 3-antigen hepatitis B virus vaccine for adults. 30 March 2022
Family-owned German drugmaker Grünenthal and NovaQuest Capital Management have entered an agreement to advance the global clinical Phase III program of Grünenthal's asset resiniferatoxin (RTX). 29 March 2022
Shares of California, USA-based IGM Biosciences were up more that 45% at $21.84 in early trading, after the announcement of a deal with French pharma major Sanofi, which, though heavily back-loaded, has the potential to earn the US biotech more than $6 billion. 29 March 2022
Adding to a growing list of major investments in AI-based life sciences companies, $150 million in series C funding has been provided to American start-up ConcertAI. 29 March 2022
Ondexxya (recommend andexanet alfa) has been approved in Japan for patients treated with the Factor Xa (FXa) inhibitors apixaban, rivaroxaban or edoxaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. 29 March 2022
Earlier this month, CNS specialist Corium won US Food and Drug Administration (FDA) approval for Adlarity (donepezil hydrochloride) to treat patients with mild, moderate, or severe dementia of Alzheimer’s disease (AD). 29 March 2022
Japan’s largest drugmaker Takeda says it has received approval from the Ministry of Health, Labor and Welfare (MHLW) for Takhzyro (lanadelumab) subcutaneous injection 300mg syringes for prophylaxis against acute attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older in Japan. 29 March 2022
March is Wilson disease awareness month – an autosomal recessive genetic disorder characterized by excess copper accumulation in the body.1 It is caused by a mutation in the ATP7B gene, with an estimated one in 90 people carrying the mutation.1 29 March 2022
East and West Coast-based American firms Biogen and Ionis Pharmaceuticals (Nasdaq: IONS) are dropping BIIB078, an amyotrophic lateral sclerosis (ALS) candidate. 29 March 2022
In what was a busy day for the Japanese regulator, the Ministry of Health, Labor and Welfare (MHLW) yesterday announced a number of approvals, both new drugs and new indications. 29 March 2022
The Drugs Controller General of India (DCGI) has recently granted emergency use authorization for US biotech Novavax’ protein-based COVID-19 vaccine for adolescents aged 12 to 18 years, which will be marketed by its partner Serum Institute of India (SII) under the brand name Covovax. 29 March 2022
China’s Innovent Biologics (HKEX: 01801) saw its shares rise 6.9% to HK$28.55 in late trading today, after it announced an expansion of its strategic collaboration with US pharma major Eli Lilly. 29 March 2022
German family-owned pharma major Boehringer Ingelheim today announced new data from the pivotal Phase II Effisayil 1 trial, presented at the 2022 American Academy of Dermatology (AAD) Annual Meeting in Boston. 28 March 2022
On February 17, 2022, Dr Robert Califf was sworn in as US Food and Drug Administration Commissioner for the second time; his first term was from February 2016 to January 2017, under the Obama administration. 28 March 2022
At this year’s annual congress of the American Academy of Dermatology (AAD), Incyte has announced new one-year results for Opzelura (ruxolitinib cream). 28 March 2022
An article has been published by The Lancet medical journal showing that Sputnik V is the world’s first COVID-19 vaccine with proven efficacy for people living with HIV. 28 March 2022
The USA-based Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of the following treatments for COVID-19: 28 March 2022
New York-based cancer giant Bristol Myers Squibb has announced that the US Food and Drug Administration has extended the review of its supplemental biologics license application (sBLA) for Reblozyl (luspatercept-aamt). 28 March 2022
Global investment firms PAI Partners and Carlyle today announced that they have agreed to acquire UK-based Theramex, a global specialty pharmaceuticals company focused on women’s health, from CVC Capital Partners VI. 28 March 2022