Latest Pharma and Biotech News
Pharmaceutical
7 April 2025 Thousands of workers dismissed from the US Department of Health and Human Services this week may soon be reinstated, after health secretary Robert F Kennedy Jr admitted that a significant share of the job cuts were made in error.
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Biotechnology
Germany-based Bayer’s wholly-owned gene therapy company AskBio today announced that its investigational gene therapy AB-1005 for the treatment of Parkinson’s disease (PD) has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the US Food and Drug Administration (FDA). 19 February 2025
Biosimilars
Icelandic biosimilar company Alvotech and Israeli drugmaker Teva Pharmaceuticals have announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, a proposed biosimilar to Eylea (aflibercept). 19 February 2025
Pharmaceutical
Australia’s Recce Pharmaceuticals has announced positive data from a Phase II trial evaluating RECCE 327 Topical Gel (R327G) for the treatment of acute bacterial skin and skin structure infections (ABSSSI), with the news pushing the firm’s shares up around 9%. 19 February 2025
Biotechnology
Boston, USA-based biotech Solid Biosciences saw its shares rocket 36% to $5.48 yesterday, after the precision genetic medicines for neuromuscular and cardiac diseases company announced positive initial data from the Phase I/II INSPIRE DUCHENNE trial evaluating SGT-003. 19 February 2025
Pharmaceutical
US biotech Gilead Sciences has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir—the company’s twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis (PrEP). 19 February 2025
Biotechnology
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to Dutch clinical-stage drug developer Merus for its petosemtamab. 19 February 2025
Pharmaceutical
Danish pharma major Novo Nordisk has sued KBP Biosciences and its founder and executive chairman, Huang Zhenhua, for $830 million in an application to the Singapore International Commercial Court. 19 February 2025
Biotechnology
US clinical-stage biotech Septerna yesterday announced its decision to discontinue the Phase I single- and multiple-ascending dose (SAD/MAD) clinical trial of SEP-786 in healthy volunteers. SEP-786 is an oral small molecule agonist of the parathyroid hormone 1 receptor (PTH1R) being developed for the treatment of hypoparathyroidism. 19 February 2025
Biotechnology
Barcelona, Spain-based biotech Ona Therapeutics today announced key leadership appointments to support its rapid growth and pipeline advancement. 19 February 2025
Pharmaceutical
Nura Bio, a US biopharma developing neuroprotective, small molecule therapies for the treatment of debilitating neurological diseases, has announced the appointments of Lahar Mehta as chief medical officer and Scott Greenberg as chief business officer. 18 February 2025
Pharmaceutical
Israel-based clinical-stage company Purple Biotech today announced it is advancing into a Phase II study with NT219 in patients with recurrent/metastatic squamous cell carcinoma. of the head and neck (R/M SCCHN), with the news pushing its shares up as much as 10% to 6.50 shekels. 18 February 2025
Biotechnology
Epitopea, an Anglo-Canadian company developing accessible, off-the-shelf RNA-based immunotherapies for cancer, has announced a license and research collaboration deal with US pharma giant Merck & Co to identify Cryptigen tumor-specific antigens (TSAs) in an undisclosed solid tumor. 18 February 2025
Pharmaceutical
Germany’s Merck KGaA has appointed three new members to its executive board, which it says is a natural evolution in the company’s leadership as it continues to implement its growth strategy. 18 February 2025
Biotechnology
Swiss dermatology company Galderma has announced two European approvals for Nemluvio (nemolizumab) to treat both atopic dermatitis and prurigo nodularis. 18 February 2025
Pharmaceutical
US pharma giant Merck & Co today announced that the European Commission (EC) has conditionally approved two indications for Welireg (belzutifan), its oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor. 18 February 2025
Pharmaceutical
Stoke Therapeutics’ stock climbed 8% early Tuesday, after the company and Biogen today announced a collaboration to develop and commercialize a treatment for Dravet Syndrome, a severe form of epilepsy that starts in childhood. 18 February 2025
Biotechnology
California-based Arcus Biosciences, a biopharma developing differentiated molecules and combination therapies for people with cancer, has presented new data for casdatifan, a HIF-2a inhibitor with best-in-class potential, in metastatic kidney cancer. 18 February 2025
Pharmaceutical
According to new research announced today, the fragile X syndrome (FXS) market across the USA and Germany is projected to experience explosive growth, quadrupling from $28.7 million in 2025 to $111.9 million by 2030, a compound annual growth rate (CAGR) of 31.3% (2025-2030), driven by the anticipated launch of two high-priced targeted therapies for FXS in 2027. 18 February 2025
Biotechnology
The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults with bullous pemphigoid (BP). 18 February 2025
Biotechnology
French clinical-stage biotech AlgoTherapeutics (AlgoTx) today announced the completion of its 276 patient Phase II trial, known as ACT, with ATX01 in chemotherapy-induced peripheral neuropathy (CIPN). 18 February 2025
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Pharmaceutical
The uveitis treatment market across seven major markets—the USA, France, Germany, Italy, Spain, the UK, and Japan—is projected to grow from $522 million in 2023 to $1.5 billion by 2033, according to a report from data analytics firm GlobalData. This marks an annual growth rate of nearly 11%. 8 April 2025
Pharmaceutical
In the USA, the layoffs at health agencies, proposed tariffs on imports and other disruptive policies under President Donald Trump have led some to express concern over a potential ‘brain drain’ impacting pharma and other industries. 8 April 2025
Biotechnology
Myricx Bio, a UK biotech focusing on the discovery and development of a novel class of payloads for antibody-drug conjugates (ADCs), is expanding its team. 8 April 2025
Biotechnology
Datroway (datopotamab deruxtecan) has been approved in the European Union (EU) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting. 8 April 2025
Pharmaceutical
US biopharma Rhythm Pharmaceuticals has announced positive topline results from the pivotal Phase III TRANSCEND trial evaluating setmelanotide, a melanocortin-4 receptor (MC4R) agonist, for the treatment of acquired hypothalamic obesity. 8 April 2025
Pharmaceutical
Indian drugmaker Sun Pharmaceutical Industries revealed it has launched fexuprazan tablets 40mg in India under the brand name Fexuclue, which is a novel potassiumcompetitive acid blocker (PCAB) that is approved as a new treatment for adults with erosive esophagitis of all grades. 8 April 2025
Biotechnology
Following hot on the heels of Monday’s European Commission EC approval of an indication extension for Johnson & Johnson’s Darzalex (daratumumab) for the treatment of adult patients with newly diagnosed multiple myeloma, comes a second EC approval today – this time in lung cancer. 8 April 2025
Pharmaceutical
Ireland’s government remains confident in its ability to retain the country’s strategic position in pharmaceutical manufacturing, despite rising tensions between the European Union and the United States over trade policy. 8 April 2025
Pharmaceutical
At the recent AD/PD 2025 International Conference on Alzheimer’s and Parkinson’s Disease (PD), Cerevance announced that solengepras, a first-in-class G-protein coupled receptor 6 (GPR6) antagonist in development for early PD, failed to meet its primary endpoint in the Phase II ASCEND trial as a monotherapy. 8 April 2025
Pharmaceutical
US biotech company Vertex Pharmaceuticals has received European Commission approval to extend the use of its cystic fibrosis therapy, Kaftrio (ivacaftor/tezacaftor/elexacaftor), in combination with ivacaftor. 8 April 2025
article
Australia’s Therapeutics Goods Administration (TGA) has issued a safety notice on isotretinoin, originally sold as Roaccutane by Swiss pharma giant Roche. 8 April 2025
Pharmaceutical
The USA’s Centers for Medicare & Medicaid Services (CMS) yesterday released the Calendar Year (CY) 2026 Rate Announcement for the Medicare Advantage (MA) and Medicare Part D Prescription Drug Programs that finalizes the payment policies for these programs. 8 April 2025
Pharmaceutical
US biotech start-up RayThera has secured $110 million in series A financing to fund the early clinical development of its small molecule drug candidates in immunology. 8 April 2025
Pharmaceutical
The UK’s Prime Minister has announced action to accelerate the discovery of life-saving drugs, improve patient care and make Britain the best place in the world for medical research. 8 April 2025
Biosimilars
Israel-based Teva Pharmaceuticals industries today revealed two important updates reflecting its commitment to expanding access to both biosimilars and innovative medicines. 7 April 2025
Pharmaceutical
Alzheon, a privately-held clinical-stage biopharma company, presented promising Phase III APOLLOE4 trial results for ALZ-801 (valiltramiprosate) in treating mild cognitive impairment (MCI) in APOE4 homozygous patients at the AD/PD 2024 International Conference on Alzheimer’s and Parkinson’s Diseases (PD). 7 April 2025
Biotechnology
South Korean clinical-stage biotech ABL Bio on Sunday announced a worldwide licensing agreement enabling GSK to develop novel medicines for neurodegenerative diseases by utilizing ABL Bio's blood-brain barrier (BBB) shuttle platform, Grabody-B. 7 April 2025
Biotechnology
China-based biotech DualityBio has named Hua Mu as its global chief medical officer, as the company prepares to ramp up its international clinical development efforts and advance toward key capital market milestones. 7 April 2025
Biotechnology
US-listed biotech CASI Pharmaceuticals has received a revised proposal from its chairman and chief executive Wei-Wu He to acquire its business in China along with certain regional rights to pipeline drugs for $20 million. 7 April 2025
Biotechnology
Italy-based Angelini Ventures, the corporate venture arm of Angelini Industries, has named Regina Hodits as managing director as it looks to scale its biotech investment activities across Europe and North America. 7 April 2025
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