Latest Pharma and Biotech News
Pharmaceutical
27 November 2024 The strain of opioid use disorder (OUD), a chronic neurological disorder characterized by the compulsive, repeated use of opioid drugs, has weighed heavily on many countries in recent years, especially the USA.
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Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeOne Medicines, formerly BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Pharmaceutical
According to a report from industry analyst DelveInsight, the market for Down syndrome treatments in the USA is now valued at almost $250 million. 27 November 2024
Pharmaceutical
The European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y, UK pharma major GSK announced today. 27 November 2024
Pharmaceutical
The strain of opioid use disorder (OUD), a chronic neurological disorder characterized by the compulsive, repeated use of opioid drugs, has weighed heavily on many countries in recent years, especially the USA. 27 November 2024
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Pharmaceutical
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 27 November 2024
Biotechnology
AI-powered protein engineering company Cradle has raised $73 million in a Series B funding. The European firm, which has now raised more than $100 million in total, calls itself the leading platform for AI-powered protein engineering. 27 November 2024
Pharmaceutical
Swiss drugmaker Idorsia was trading more than 10% higher by lunchtime on Wednesday. Idorsia earlier announced that it has entered into exclusive negotiations with an undisclosed party for the global rights to aprocitentan. 27 November 2024
Biosimilars
Samsung Bioepis has appointed Kyung-Ah Kim as its new president and chief executive, succeeding Christopher Hansung Ko, who will lead the Samsung Future Business Division. 27 November 2024
Biotechnology
US clinical stage biotech Alector saw its shares tumble 35% to $2.57 by close of trading yesterday, as it announced disappointing results from the INVOKE-2 Phase II clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). 27 November 2024
Pharmaceutical
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
Pharmaceutical
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
Biotechnology
PTC Therapeutics has announced that its Phase II trial for utreloxastat, aimed at treating amyotrophic lateral sclerosis (ALS), failed to meet its primary endpoint. 27 November 2024
Biotechnology
US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement. 26 November 2024
Pharmaceutical
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) today announced that Dr Thomas Schinecker, chief executive (CEO) of Swiss pharma giant Roche (ROG: SIX), will take up the post as president of the trade association effective January 1, 2025. 26 November 2024
Pharmaceutical
US central nervous system (CNS) disorders specialist Axsome Therapeutics today released encouraging late-stage results for its narcolepsy candidate AXS-12 (reboxetine), sending its shares edging up 2.6% to $100.00 in pre-market activity. 26 November 2024
Biotechnology
Clinical-stage US CAR-T therapies developer Poseida Therapeutics saw its shares skyrocket 227% to $9.36 pre-market today, on the news of a proposed takeover by Swiss pharma giant Roche. 26 November 2024
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Pharmaceutical
Indian generic drugmaker Dr Reddy’s Laboratories says it has acquired the trademark rights of the breast cancer drug Primcyv (palbociclib) from Pfizer Products India for use in the Indian market. 16 January 2023
Biotechnology
French biotech Abionyx Pharma has reported that the pilot Phase IIa trial of CER-001 as a treatment for septic patients at high risk of developing acute kidney injury (AKI) met its primary objective. 16 January 2023
Biotechnology
The US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have released a statement on stroke cases among people given an updated, bivalent COVID-19 vaccine. 16 January 2023
Pharmaceutical
Large pharmaceutical firms are increasingly upset at the deal they agreed with the British government on drug pricing, the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS). 16 January 2023
Biotechnology
Shares of Japanese drugmaker Eisai were lifted by more than 3% to 8,327 yen this morning, after it revealed it has filed for domestic approval of its Alzheimer’s drug Leqembi (lecanemab), which was granted accelerated approval in the USA earlier this month. 16 January 2023
Biotechnology
London-listed Finnish biotech firm Faron Pharmaceuticals saw its share rise 11.4% to 351.00 pence this morning after it released positive early-stage clinical data on its novel precision cancer immunotherapy candidate. 16 January 2023
Biotechnology
Japanese companies have been late to progress COVID-19 vaccines, so news that Daiichi Sankyo had now filed for regulatory approval of its vaccine candidate sent the company’s shares up 2.2% to 4,134 yen on Friday. 16 January 2023
Pharmaceutical
The cardiomyopathies market in the 68 major world markets (68M) is set to grow from $3.07 billion in 2021 to $9.63 billion in 2031 at a compound annual growth rate (CAGR) of 12.1%. 16 January 2023
Biotechnology
The past week kicked off with several M&A deals being announced. The largest of these was by UK pharma major AstraZeneca revealing that is acquiring CinCor Pharma for up to $1.8 billion, with the aim of expanding it cardiorenal portfolio and pipeline as well as blood pressure drug baxdrostat. Also, French drugmaker Ipsen announced a takeover bid for USA-based Albireo in a deal worth almost $1 billion, bringing with it rights to liver disease drug Bylvay. Arecor Therapeutics reached a key milestone in the development of the ready-to-use injectable AT307 in its partnership with Hikma Pharmaceuticals but the latter also returned rights to another candidate, AT282. Privately-held US mRNA specialist Anima Biotech entered into a collaboration with US pharma major AbbVie to develop cancer and immune disorder therapies. 15 January 2023
Pharmaceutical
The Type 2 diabetes (T2D) market is a crowded and competitive landscape with multiple ‘me-too’, generic and biosimilar drugs entering the sector. Growth will be primarily driven by the launch of novel blockbuster therapies and an increasing diagnosed prevalent population across the nine major markets. (9MM). 14 January 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has approved a label update for Rybelsus (semaglutide) tablets 7mg or 14mg, allowing use as a first-line treatment option for adults with type 2 diabetes who have not previously taken a diabetes treatment. 13 January 2023
Biotechnology
Fatal cases of acute liver failure reported in patients treated with Zolgensma (onasemnogene abeparvovec) were raised this week at the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC). 13 January 2023
Biotechnology
AstraZeneca is to pull its leukemia antibody-drug conjugate Lumoxiti (moxetumomab pasudotox-tdfk) from the US market later this year. 13 January 2023
Pharmaceutical
A Phase III trial miss has hollowed out the share price of Israel-headquartered clinical-stage diabetes specialist Oramed Pharmaceuticals. 13 January 2023
Biosimilars
Shares of India’s largest biotech firm Biocon slumped 2.4% to record a new 52-week low, after its subsidiary Biocon Biologics informed that the US Food and Drugs Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for its Insulin-R product. 13 January 2023
Pharmaceutical
US a multi-asset longevity biotech Cambrian Biopharma yesterday unveiled its latest pipeline company, as Isterian Biotech. emerged from stealth, headquartered in New York. 13 January 2023
Biotechnology
The US Food and Drug Administration’s (FDA) recent approval of TG Therapeutics’ Briumvi (ublituximab) against relapsing forms of multiple sclerosis (MS) is welcome news for the company after suffering a major setback in 2022 when the FDA extended its review of Briumvi by three months. 13 January 2023
Pharmaceutical
The United Arab Emirates (UAE) ranks first regionally in attracting multinational pharmaceutical companies. 13 January 2023
Generics
A sudden surge in Covid cases in China has made anti-Covid generic drugs from India attractive, including the generic version of Pfizer's anti-Covid oral drug Paxlovid (nirmatrelvir/ritonavir), which is in high demand and needs to be reserved weeks in advance, reports The Pharma Letter's local correspondent, 12 January 2023
Pharmaceutical
China’s National Medical Products Administration (NMPA) has approved Japanese pharma giant Takeda’s Exkivity (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. 12 January 2023
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