Latest Pharma and Biotech News
Pharmaceutical
2 April 2025 Freed from their former obligations to remain loyal to agency and state, a number of high-profile figures from the US Food and Drug Administration (FDA) have sounded the alarm about its direction of travel under Robert Francis Kennedy Jr (RFK Jr), the new Secretary of Health and Human Services.
Today's issue
Refine Search
Generics
Even as the spectre of tariffs looms over the pharmaceutical trade between India and the USA, presenting a complex scenario with potential repercussions for both regions, its implementation would necessitate a rapid recalibration of supply chains and pricing strategies, reports The Pharma Letter’s India correspondent. 3 March 2025
Biotechnology
The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for Anktiva (nogapendekin alfa inbakicept-pmln) and CAR-NK (PD-L1 t-haNK) for the reversal of lymphopenia in patients receiving standard-of-care chemotherapy/radiotherapy and in multiply relapsed locally advanced or metastatic pancreatic cancer. 3 March 2025
Pharmaceutical
UK-based specialty drugmaker Kelso Pharma has appointed experienced pharma executive, Giovanni Mauri, as general manager at Velit Biopharma, the Italian-based pharma business that was acquired by Kelso in November 2023. 3 March 2025
Pharmaceutical
Among significant research news last week, US CNS specialist Axsome Therapeutics released new Phase III data on its recently US Food and Drug Administration (FDA)-approved migraine drug Symbravo, and the UK’s AstraZeneca announced positive Phase III trial results for its breast cancer candidate camizestrant. US biotech giant Amgen revealed it is pressing ahead with its $200 million investment in Indian technology center. US pharma major Eli Lilly attracted attention with its licensing deal for Organovo’s FXR program and announcing the release of new dosages and prices for its blockbuster obesity drug Zepbound. 2 March 2025
Pharmaceutical
Massachusetts, USA-based start-up Magnet Biomedicine, which is advancing molecular glue discovery with rational selection and design, has announced a collaboration and license agreement with pharma major Eli Lilly & Co to discover, develop, and commercialize molecular glue therapeutics in oncology. 1 March 2025
Biotechnology
The US President Donald Trump began his second term with a series of directives targeting the US National Institutes of Health (NIH), creating uncertainty around NIH grant funding for biopharmaceutical drug development. 1 March 2025
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended three novel medicines for approval at its February 2025 meeting. The European Commission is expected to announce a final decision on approval in the coming months. 1 March 2025
Pharmaceutical
Medicare Part D spending for 10 selected diabetes drugs in the USA totaled $35.8 billion in 2023, an increase of 364% from 2019. 28 February 2025
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved an mRNA respiratory syncytial virus (RSV) vaccine (brand name mRESVIA) to protect patients aged 60 and over against lower respiratory tract disease caused by RSV. 28 February 2025
Pharmaceutical
Japanese biopharma Nxera Pharma has announced two deals in a single day with partners that will commercialize its products in parts of Asia. 28 February 2025
Biotechnology
Sino American biotech BeiGene has announced financial results and corporate updates from the fourth quarter and full year 2024. The company’s shares rose 7.5% to $278.38 on the news. 28 February 2025
Pharmaceutical
South Korean vaccine maker SK bioscience today revealed that it has received prior notification from the Pan American Health Organization (PAHO), a specialized agency of the United Nations in charge of international health cooperation in the Americas, to supply its self-developed varicella (chickenpox) vaccine, SKYVaricella, to Latin America through 2027. 28 February 2025
Pharmaceutical
Encephalitis is a complex and often devastating condition that can leave lasting neurological damage in survivors. Despite advancements in medical science, effective treatments remain limited, and many cases still go undiagnosed or misattributed. 28 February 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Odactra tablet for use in young children with house dust mite (HDM) allergy, from Danish allergy expert ALK Abello. 28 February 2025
Biotechnology
Duality Biologics, a Chinese biotech specializing in antibody-drug conjugates (ADCs), has opted not to move forward at this time with a plan to list on the Hong Kong Stock Exchange. 28 February 2025
Pharmaceutical
Kallyope’s latest obesity drug trial results show modest weight-loss effects that lag behind competing therapies in the increasingly competitive obesity treatment market. 28 February 2025
Pharmaceutical
Neurocrine Biosciences has announced positive results from its Phase IV KINECT-PRO study, showing that Ingrezza (valbenazine) provided meaningful and sustained benefits for patients with tardive dyskinesia (TD). 28 February 2025
Generics
Israeli drug manufacturer Teva Pharmaceutical Industries has resumed the deliveries of the scarce epilepsy drug Finlepsin retard (carbamazepine) to the Russian market, which is aimed to alleviate shortages of the product, reports The Pharma Letter’s local correspondent. 28 February 2025
Pharmaceutical
A pair of Republicans have reintroduced the bicameral Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act. 28 February 2025
Pharmaceutical
Rare Disease Day, held annually on 28th February, raises awareness of people living with rare diseases across the world, their families, and their carers. The key aims of the campaign are to achieve equitable access to diagnosis, treatment, and social opportunity for those affected by rare diseases. 28 February 2025
All news
Pharmaceutical
US pharma major Eli Lilly’s brand value has surged by 108% since entering the weight loss market in 2023, according to a new report from Brand Finance. 3 April 2025
Biotechnology
US biotech BioMarin Pharmaceutical yesterday revealed that the Phase III PEGASUS trial evaluating Palynziq (pegvaliase-pqpz) met its primary efficacy endpoint, demonstrating a statistically-significant lowering in blood phenylalanine( Phe) levels in adolescents aged 12-17 with phenylketonuria (PKU) compared to diet alone. 3 April 2025
Biotechnology
Sino-American biotech BeiGene today revealed it intends to discontinue its clinical development program for ociperlimab (BGB-A1217), an anti-TIGIT antibody, as a potential treatment for lung cancer. 3 April 2025
Biotechnology
Australian biotech major CSL Limited subsidiary CSL Behring today announced that it has successfully concluded negotiations in Germany with the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds) resulting in national reimbursement of Hemgenix (etranacogene dezaparvovec). 3 April 2025
Pharmaceutical
Colorado, USA-based Edgewise Therapeutics, a muscle disease-focused biopharma company, closed 23% lower after Wednesday’s trading. 3 April 2025
Pharmaceutical
With two new lawsuits, Eli Lilly has escalated its legal campaign against the makers of unauthorized versions of its diabetes and weight-loss drugs, Mounjaro (tirzepatide) and Zepbound (tirzepatide), challenging inroads made by drug compounders in what has become a highly lucrative market. 3 April 2025
Generics
US generic manufacturer Padagis has received clearance to extend the shelf life of its over-the-counter naloxone nasal spray to 36 months, as the company looks to bolster value and accessibility in a crowded but critical public health market. 3 April 2025
Pharmaceutical
Pharmaceuticals will be exempt from the tariffs on imports to the USA that were announced by US President Donald Trump Wednesday, according to a White House fact sheet. 3 April 2025
Pharmaceutical
Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Vanrafia (atrasentan), a potent and selective endothelin A (ETA) receptor antagonist, for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. 3 April 2025
Biotechnology
US clinical-stage biotech Nurix Therapeutics announced that Sanofi has exclusively licensed an undisclosed Nurix program targeting a previously undruggable transcription factor for autoimmune diseases. 3 April 2025
Biotechnology
North Carolina, USA-based clinical-stage gene therapy company Atsena Therapeutics has announced the successful closing of an oversubscribed $150 million Series C financing. 3 April 2025
Biotechnology
Swiss clinical-stage biotech AC Immune’s shares closed up 5.9% at $1.90 yesterday, after it announced additional interim safety and positive immunogenicity data from the Phase II VacSYn clinical trial evaluating ACI-7104.056, its wholly owned anti-alpha-synuclein (a-syn) active immunotherapy candidate, for the treatment of patients with early Parkinson’s disease (PD). 3 April 2025
Biotechnology
The European Medicines Agency has temporarily suspended enrollment and dosing in a Phase II trial of Sarepta Therapeutics' gene therapy, Elevidys (delandistrogene moxeparvovec-rokl), for Duchenne muscular dystrophy (DMD). 3 April 2025
Pharmaceutical
CNS specialist Axsome Therapeutics has announced results from the PARADIGM Phase III proof-of-concept trial of solriamfetol in major depressive disorder (MDD) with and without severe excessive daytime sleepiness (EDS). 3 April 2025
Biotechnology
Swiss pharma major Roche said a higher-dose version of its top-selling multiple sclerosis drug Ocrevus (ocrelizumab) failed to deliver additional benefit in slowing disability progression, compared to the currently approved dose, in a Phase III trial. 3 April 2025
Biotechnology
US biotech Inhibrx Biosciences has announced a leadership shake-up following the departure of co-founder Brendan Eckelman, who is leaving to establish a new privately-held biotech company. 2 April 2025
Biotechnology
Swedish Orphan Biovitrum, the Nordic biotech also known as Sobi, has announced that the National Institute for Health and Care Excellence (NICE) has issued its final guidance in England and Wales recommending the use of Altuvoct (efanesoctocog alfa). 2 April 2025
Biotechnology
US biotech Artis BioSolutions has officially launched with the acquisition of Landmark Bio, a translational development and manufacturing group formed through an alliance of academic and industry stakeholders. 2 April 2025
Biotechnology
The UK’s health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended brentuximab vedotin in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with untreated stage 3 or 4 CD30+ Hodgkin lymphoma (HL), within final draft guidance (FDG). 2 April 2025
Generics
German tech conglomerate Siemens has signed an agreement with Miko Pharma to develop facilities for the local production of generic pharmaceuticals in Ghana. 2 April 2025
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Copyright © The Pharma Letter 2025 | Headless Content Management with Blaze