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
Transdermal cannabinoid specialist Zynerba Pharmaceuticals’ pipeline drug Zygel is expected to achieve $18.1 million in sales by 2030, according to GlobalData, due to its potential to help fragile X syndrome (FXS) patients with irritability or aggression symptoms. 23 March 2022
China’s Fosun Pharma’s biotech arm Henlius is preparing to get its PD1 antibody serplulimab into hospitals nationwide once it is approved in China, and supply its four approved biosimilars with enhanced manufacturing capacity, said Henlius chief executive Zhang Wenjie at a press meeting held in Shanghai on March 17. 22 March 2022
The federal government of Australia will invest A$28.1 million ($20.9 million) into a new agency for the Health Portfolio, Genomics Australia, it has been announced. 22 March 2022
The UK’s medicine costs watchdog the National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending US biotech company BioMarin Pharmaceutical Vimizim (elosulfase alfa) for routine use in the National Health Service (NHS) for the treatment of mucopolysaccharidosis type 4A (also known as MPS 4A and Morquio A syndrome). 22 March 2022
Swedish biopharma Calliditas Therapeutics saw its shares fall almost 6% to 84.90 kronor today, after it announced that there would be a delay in the European approval of its new oral formulation of budesonide, developed under the project name Nefecon. 22 March 2022
New results from a trial testing CAR T-cell therapy axicabtagene ciloleucel (axi-cel) indicate it could be used to effectively treat people with high-risk large B-cell lymphoma (LBCL). 22 March 2022
The US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) for patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. 22 March 2022
US biotech start-up Affini-T Therapeutics today announced the completion of an oversubscribed $175 million financing that was co-led by Vida Ventures and Leaps by Bayer. 22 March 2022
Japan’s Eisai and Biogen today announced that the latest findings on lecanemab, an investigational anti-amyloid-beta (Abeta) protofibril antibody being developed for the treatment of early Alzheimer's disease (AD), were presented at the Abeta Targeted Therapies in AD 2 Symposium at the 2022 International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) March 15-20 in Barcelona, Spain and virtually. 22 March 2022
Germany’s STADA Arzneimittel outperformed the market again in 2021, overcoming challenging trading conditions to report 8% sales growth to 3.25 billion euros ($3.59 billion) and a 37% increase in profit as earnings before interest, tax, depreciation and amortization (EBITDA) to 776.5 million euros, the company announced today. 22 March 2022
Innovative treatments and medicines developed by the pharmaceutical industry in Latin America not only save lives, but also create jobs, help reduce health spending and raise quality of life standards, The Pharma Letter’s local correspondent writes. 22 March 2022
The Rhode Island attorney general on Monday announced a settlement with Israeli generics giant Teva Pharmaceutical Industries and several of its affiliates worth about $100 million, including $28.5 million in cash in addition to drug donations to treat opioid addiction, that was reached ahead of opening arguments in the state's trial over the company's alleged role in the opioid crisis. 22 March 2022
In support of US President Joe Biden’s Cancer Moonshot℠goal of fostering data sharing in cancer research, the National Cancer Institute, part of the National Institutes of Health, has launched the Molecular Characterization Initiative for pediatric tumors. 22 March 2022
Volastra Therapeutics, a US biotech firm focused on exploiting chromosomal instability (CIN) as a vulnerability for cancer cells, has signed a collaboration with US pharm major Bristol Myers Squibb to discover, develop and commercialize new medicines. 21 March 2022
US antibody-drug conjugate (ADC) specialist ImmunoGen has announced full results from the pivotal SORAYA trial evaluating the efficacy and safety of mirvetuximab soravtansine (mirvetuximab: IMGN853) monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with Avastin (bevacizumab). 21 March 2022
US pharma major Bristol Myers Squibb closed higher on Friday following news on a new product named Opdualag (nivolumab and relatlimab-rmbw). 21 March 2022