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Biotechnology
Germany’s Evotec says it has taken notice of the statement made by Halozyme Therapeutics on November 22, stating that it has withdrawn its non-binding proposal to acquire Evotec for 11.00 euros per share in cash. 23 November 2024
Biotechnology
Colorado, USA-based OncoVerity announced the closing of a series A extension led by existing investors, argenX and RefinedScience. The value was not disclosed, but this extension follows a $30 million Series A fundraiser in March 2023. 22 November 2024
Biotechnology
Sweden-based BioArctic saw its fall 7.5% to 139.90 kronor on Friday, after its announced that its partner, Japan’s Eisa, has updated its revenue outlook for the Alzheimer’s treatment Leqembi (lecanemab) for the 2024 fiscal year (FY), which runs from April 2024 through March 2025. 11 November 2024
Biotechnology
Danish biotech Gubra announces that Germany’s Boehringer Ingelheim has decided to discontinue the development of the long-acting neuropeptide Y receptor type 2 (NPY2R) agonist BI 1820237 in obesity. 4 November 2024
Biotechnology
Japanese drugmaker Eisai has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (US brand name Leqembi) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA. 1 November 2024
Pharmaceutical
GSK has announced its largest US manufacturing investment to date, dedicated to producing medicines and vaccines. 25 October 2024
Pharmaceutical
Following a re-examination, the European Medicines Agency’s human health committee, CHMP confirmed its initial recommendation to refuse the granting of a conditional marketing authorization for Masitinib AB Science’s masitinib. 18 October 2024
Pharmaceutical
University Medical Center Groningen (UMCG) and SHINE Europe have secured a 10.5 million euro ($11 million) grant to advance European production of terbium isotopes for cancer treatments. 17 October 2024
Pharmaceutical
Danish dermatology focused LEO Pharma has announced the launch of Anzupgo (delgocitinib) cream in Germany for the treatment of adult patients with moderate to severe chronic hand eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate. 15 October 2024
Pharmaceutical
French pharma major Sanofi revealed it has entered into negotiations with private equity firm Clayton Dubilier & Rice (CD&R) for the potential sale of a 50% controlling stake in Opella, its consumer healthcare business. 14 October 2024
Pharmaceutical
The UK’s new 2024 voluntary scheme for branded medicines pricing, access, and growth (VPAG) came into force at the beginning of January this year. 4 October 2024
Biotechnology
Sirnaomics, a firm specializing in RNAi therapeutics, has entered into a subscription agreement with biotech specialist Poon Hung Fai. 4 October 2024
Biotechnology
GigaGen has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS). 4 October 2024
Biotechnology
Oxford, UK-based Enara Bio today announces the closing of a $32.5 million Series B financing supported by a strong syndicate of new and existing biotech investors. 3 October 2024
Pharmaceutical
French drugmaker Mitem Pharmavhas the worldwide acquisition of Desferal (deferoxamine), a major MITM in hematology, from Swiss giant Novartis. 25 September 2024
article
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) has elected Bruno Sepodes as its new chair. 19 September 2024
Pharmaceutical
The Austrian Academy of Sciences (OeAW) is further expanding its focus on life sciences by opening an institute for biomedical artificial intelligence (AI) based on a 150 million euros ($166.8 million) funding from the German non-profit Boehringer Ingelheim Foundation (BIS). 18 September 2024
Biotechnology
Zenas BioPharma announced the pricing of its upsized initial public offering of 13,235,294 shares of its common stock at an initial public offering price of $17.00 per share. 13 September 2024
Biotechnology
US pharma major Eli Lilly and Egyptian firm EVA Pharma have entered into an agreement to expand access to Olumiant (baricitinib) to an estimated 20,000 people in 49 low- to middle-income countries in Africa by 2030. 6 September 2024
Biotechnology
British pharma major AstraZeneca has chosen Shanghai as the location for what will become its fifth global strategic center for research and development. 29 February 2024
Pharmaceutical
US gastroenterology specialist Ironwood Pharmaceuticals saw its shares plunge more than 30% to $10.50 in pre-market activity today, after it announced what it called ‘positive’ top-line results from its pivotal Phase III STARS trial. 29 February 2024
Biotechnology
Avidity Biosciences has announced an oversubscribed $400 million private placement, with the news sending the US RNA-focussed biotech firm’s shares up 21.8% to $18.58 by mid-morning. 29 February 2024
Biotechnology
San Diego, USA-based Kenai Therapeutics, a biotech leveraging induced pluripotent stem cell (iPSC) tech to discover and develop a platform of allogeneic neuron replacement cell therapies for neurological disorders, has raised $82 million in a Series A financing. 29 February 2024
Pharmaceutical
Indian drugmakers plan to accelerate their expansion in the Russian pharmaceutical market this year, which will be achieved by the building of several large-scale manufacturing facilities within the territory of the country, reports The Pharma Letter’s local correspondent. 29 February 2024
Biotechnology
Denmark-based life sciences investor Novo Holdings today announced it had launched Orbis Medicines, a leader in macrocycle drug discovery, to advance the development of next-generation oral macrocycle drugs. 29 February 2024
Pharmaceutical
Cannabinoid and psychedelic medicine company Incannex Healthcare closed 49% higher after Wednesday’s trading. 29 February 2024
Generics
Swiss generics and biosimilars drugmaker Sandoz today announced that its US subsidiaries – Sandoz Inc and Fougera Pharmaceuticals - have entered into a settlement agreement with the class of direct purchaser plaintiffs in the multidistrict litigation entitled In re Generic Pharmaceuticals Pricing Antitrust Litigation in the US District Court for the Eastern District of Pennsylvania. 29 February 2024
Pharmaceutical
Last month, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the refusal of the marketing authorization for Nezglyal (leriglitazone) following a re-examination of the filing. 29 February 2024
Generics
The tides are shifting. As multinational entities such as Novartis, AstraZeneca and Sanofi recalibrate their strategies in India, spurred by intensified local competition and patent expiries, domestic pharma players like Cipla, Torrent Pharma, Eris Lifesciences, and JB Chemicals are asserting their prominence. 29 February 2024
Pharmaceutical
Shares in New Jersey, USA-based Palatin Technologies fell over a third on Wednesday, after a key Phase III trial missed its efficacy goals. 29 February 2024
Pharmaceutical
Australian medicines regulator the Therapeutic Goods Administration (TGA) has begun a targeted consultation process as part of a proposal to change the Therapeutic Goods Regulations 1990 to remove all medicines containing glucagon-like-peptide-1 (GLP-1) receptor agonist analogues (GLP-1 RAs), including semaglutide-like medicines, from the pharmacist extemporaneous compounding exemptions. 29 February 2024
Pharmaceutical
Process changes for the assessment of established medicines have been published by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), in new guidance which will come into effect on Friday March1, 2024. 29 February 2024
Biotechnology
Swiss biotech Idorsia closed down more than 9% at 2.59 francs today, on news of a deal for two of its assets. 28 February 2024
Biosimilars
Medicines for Europe, a trade group for the European generics industry, has welcomed the position adopted today by the European Parliament regarding SPC regulation. 28 February 2024
Pharmaceutical
USA-based rare disease Applied Therapeutics today announced that the US Food and Drug Administration (FDA) has accepted the filing of the New Drug Application (NDA) for govorestat (AT-007) for the treatment of classic galactosemia 28 February 2024
Pharmaceutical
Riding high after a high-profile victory over erstwhile US President Donald Trump, New York Attorney General Letitia James has set her sights on another emotive issue - the safety of certain medicines given to children. 28 February 2024
Biotechnology
San Diego, USA-based Janux Therapeutics has seen its share price triple after positive early data were announced for JANX007 and JANX008. 28 February 2024
Pharmaceutical
Indian drugmaker Cipla Limited says it has received approval from the Central Drugs Standard Control Organization (CDSCO) to market the novel antibiotic Zemdri (plazomicin) in India. 28 February 2024
Biotechnology
French immunotherapy company OSE Immunotherapeutics was trading more than 50% higher by late Wednesday. 28 February 2024
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