Pharma & Biotech Pricing, Policy & Regulation
Pharmaceutical
The share prices of Pfizer, GSK, Novavax and other vaccine companies were all markedly lower on Friday. This was not due to the publication of disappointing research results in the sphere, or an ominous stance taken by a major regulator on a key filing, but rather a political development that could spell trouble for the vaccines field as a whole. 15 November 2024
Today's issue
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Biotechnology
Zhongshan-based biopharma company Akeso will await the verdict of the Chinese medicines regulator on a penpulimab-based combo therapy. 22 November 2024
Pharmaceutical
The nomination of Robert F Kennedy Jr — known as RFK Jr — for the role of US Secretary of the Department of Health and Human Services (HHS) President-elect Donald Trump sent shares in vaccine companies sharply downwards. 22 November 2024
Biotechnology
British pharma major AstraZeneca is facing challenges in its bid to secure full approval for its anticoagulant reversal therapy, Andexxa (andexanet alfa), in the USA. 22 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 2024
Biotechnology
Astellas Pharma has been hit by bad news from the US Food and Drug Administration, which will not currently approve the firm’s request to supplement the label for Izervay (avacincaptad pegol). 21 November 2024
article
The UK government has reappointed BioIndustry Association (BIA) chairman Daniel Mahony as its Life Sciences Investment Envoy. 21 November 2024
Biotechnology
The European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab), from US pharma giant Pfizer. 20 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Pharmaceutical
Anthony Harnden has been appointed as the new chair of the UK’s Medicine and Healthcare products Regulatory Agency (MHRA). 20 November 2024
Biotechnology
The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) says that talks with the makers of Enhertu have ended without agreement, meaning guidance that does not recommend Enhertu for advanced breast cancer will remain unchanged. 20 November 2024
Pharmaceutical
Australia’s Therapeutic Goods Administration (TGA) yesterday warned that health professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under six years of age. 20 November 2024
Biotechnology
Germany’s Lindis Biotech, a specialist in multi-specific antibody platforms, has announced an exclusive licensing agreement with Pharmanovia, for the commercialization of Korjuny (catumaxomab). 19 November 2024
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday approved the medicine Filspari (sparsentan) from Vifor France to treat primary immunoglobulin A nephropathy (IgAN). 19 November 2024
Biosimilars
Following US approval in May this year, South Korea’s Samsung Bioepis and US biotech Biogen have now won approval from the European Commission (EC) for their Opuviz 40mg/mL solution for injection in a vial, a biosimilar referencing Regeneron and Bayer’s Eylea (aflibercept). 18 November 2024
Biotechnology
Shanghai-based Junshi Biosciences has received UK regulatory approval for Loqtorzi (toripalimab) in nasopharyngeal carcinoma (NPC) and esophageal squamous cell carcinoma (ESCC). 18 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent(dupilumab), Regeneron and partner Sanofi revealed late Friday. 18 November 2024
Pharmaceutical
The Danish government’s newly-unveiled health reform has been praised for tackling chronic disease care and health inequalities while driving health innovation. 18 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Syndax Pharmaceuticals’ Revuforj (revumenib). 18 November 2024
Pharmaceutical
New research published by the European Federation of Pharmaceutical Industries and Associations (EFPIA) provides in-depth analysis of the economic footprint of the pharmaceutical industry in Europe, across member states and compares Europe to other regions of the world. 18 November 2024
Pharmaceutical
Australia’s Starpharma has announced that it has completed the formal dispute resolution process with the US Food and Drug Administration (FDA) in relation to VivaGel BV (SPL7013/astodrimer sodium). 20 February 2024
Generics
US generic drug-focussed drugmaker Viatris today announced that its Aurangabad, India, facility has received certification from the British Standards Institution (BSI) for meeting a new industry standard on minimized risk of antimicrobial resistance (AMR). 20 February 2024
Pharmaceutical
The European Commission (EC) has granted marketing authorization for Velsipity (etrasimod) to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC). 19 February 2024
Generics
Reform of the procurement policies applied to generic medicines is needed to ensure greater security of supply for patients and health systems, according to Medicines for Europe. 19 February 2024
Generics
Indian generic drugmaker Aurobindo Pharma has come under scrutiny from the US Food and Drug Administration (FDA) due to compliance issues detected at its formulation manufacturing facility, Eugia Unit III. 19 February 2024
Biotechnology
The Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy. 19 February 2024
Generics
India-based generic drugmaker Lupin Limited (BSE: 500257) has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Minzoya (levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets), 0.1 mg/0.02 mg and 36.5 mg, to market a generic equivalent of Balcoltra of USA-based specialty drugmaker Avion Pharmaceuticals. 19 February 2024
Biotechnology
The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Amtagvi (lifileucel) suspension for intravenous infusion, submitted by US biotech Iovance Biotherapeutics. 19 February 2024
Pharmaceutical
UK pharma major AstraZeneca’s shares were up 2.7% at 10,094 pence Friday, after it revealed that its Tagrisso (osimertinib) with the addition of chemotherapy has been approved in the USA for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). 19 February 2024
Biotechnology
M&A continued to feature in the news last week, as Gilead Sciences announced plans to acquire fellow USA-based CymaBay Therapeutics and its liver disease candidate seladelpar for around $4.3 billion. On a negative development, AN2 Therapeutics saw its market capitalization crash 74% after it revealed it is pausing enrollment of a Phase III study of epetraborole in lung cancer, Also of note, Brii Biosciences announced another research collaboration with VBI Vaccines in lung cancer. Sarepta Therapeutics announced that the US Food and Drug Administration (FDA) has accepted its application for an extended indication for its Duchenne muscular dystrophy drug Elevidys. 18 February 2024
Biotechnology
The US Food and Drug Administration (FDA) has approved Xolair (omalizumab) for the reduction of allergic reactions to one or more foods , Swiss pharm giant Roche announced on Friday. 17 February 2024
Biotechnology
The Food and Drug Administration (FDA) has accepted and filed the efficacy supplement to the Biologics License Application (BLA) for Elevidys (delandistrogene moxeparvovec-rokl) submitted by US precision genetic medicines firm Sarepta Therapeutics. 16 February 2024
Biotechnology
The US Food and Drug Administration yesterday revealed it has granted traditional approval for Tepmetko (tepotinib,) from EMD Serono, a US subsidiary of Germany’s Merck KGaA. 16 February 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Augtyro (repotrectinib). 16 February 2024
Biotechnology
The Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in people aged 12 years and older whose disease is not adequately controlled with existing therapy. 16 February 2024
Biotechnology
The UK's National Institute for Health and Care Excellence (NICE) has issued a Final Draft Guidance (FDG) recommending GSK’s Omjjara (momelotinib) for myelofibrosis-related splenomegaly or symptoms in adults with moderate to severe anaemia who have not had a JAK-inhibitor or had Jakafi (ruxolitinib). 15 February 2024
Biotechnology
US biopharma Citius Pharmaceuticals has announced the resubmission of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Lymphir (denileukin diftitox) for patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. 15 February 2024
Generics
The USA’s Federal Trade Commission (FTC) and Department of Health and Human Services (HHS) yesterday jointly issued a Request for Information to understand how the practices of two types of pharmaceutical drug middlemen groups - group purchasing organizations (GPOs) and drug wholesalers - may be contributing to generic drug shortages. 15 February 2024
Biosimilars
India has achieved a notable milestone in the field of cancer treatment with its indigenously developed CAR-T cell therapy, resulting in the first patient being declared cancer-free post treatment. 15 February 2024
Pharmaceutical
Today, the US Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. 14 February 2024
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