Pharma & Biotech Pricing, Policy & Regulation
Pharmaceutical
In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards. 25 November 2024
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Biotechnology
New Zealand’s Pharmaceutical Management Agency PHARMAC said today that it proposes to fund cetuximab (Erbitux) from February 1, 2018 for the treatment of patients with locally advanced, non-metastatic, squamous cell cancer of the head and neck subject to certain clinical criteria being met. 15 November 2017
Pharmaceutical
Announcing his pick for the next Health and Human Services (HHS) Secretary in a Tweet on Monday, US President Donald Trump returned to the rhetoric of his sporadic outbursts on pharmaceutical product prices once more. 14 November 2017
Pharmaceutical
The US Food and Drug Administration (FDA) has approved the first drug with a digital ingestion tracking system. 14 November 2017
Pharmaceutical
Following a nine-month public process, the USA’s Institute for Clinical and Economic Review (ICER) yesterday posted the final modifications to its value assessment framework for reviews of certain treatments for serious, ultra-rare diseases. 14 November 2017
Biosimilars
The European Commission followed in the footsteps of the US Food and Drug Administration (FDA) by approving the Humira (adalimumab) biosimilar being developed by privately-owned drugmaker Boehringer Ingelheim. 13 November 2017
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has published draft guidance today that does not recommend Revestive (teduglutide) for treatment of people with short bowel syndrome (SBS). 13 November 2017
Biotechnology
With over 7,000 medicines in development, new treatments will continue to change patients’ lives, slowing disease progression, avoiding illness and reducing overall costs for healthcare systems. But developing a new medicine is a long, complex and risky process with no guarantees of success. 13 November 2017
Pharmaceutical
In the field of M&A last week, attracting a great deal of attention was debt-ridden Canadian firm Valeant Pharmaceuticals International's sale of its subsidiary Sprout Pharmaceuticals. The regulatory arena saw US Food and Drug Administration approvals for: Roche’s cancer drug Alecensa; Seattle Genetics’ Adcetris for lymphoma; and Dynavax’ hepatitis B drug Heplisav-B. Sage Therapeutics’ Phase III trial of brexanolone in postpartum depressive disorder raised questions on what this would mean for Marinus Pharmaceuticals, and Sanofi’s deal with Principia Biopharma for a novel multiple sclerosis candidate PRN2246 also raised comments. 12 November 2017
Biotechnology
The US Food and Drug Administration approved Cinvanti (aprepitant) injectable emulsion, for intravenous infusion, from US specialty biotech firm Heron Therapeutics, for the prevention of acute and delayed nausea and vomiting associated with chemotherapy in adult patients. 11 November 2017
Biotechnology
The European Medicines Agency has concluded its review of the multiple sclerosis medicine Zinbryta (daclizumab) and confirmed further restrictions to reduce the risk of serious liver damage, the EMA announced on Friday. 11 November 2017
Pharmaceutical
The US Food and Drug Administration has accepted for review the New Drug Application (NDA) for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) being evaluated for the treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults by US drugmaker Sunovion Pharmaceuticals. 10 November 2017
Pharmaceutical
Shares in California's Dynavax Technologies are up about 4% in New York after the company announced its Heplisav-B (hepatitis B vaccine) has been approved in the USA. 10 November 2017
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended seven new drugs for approval, including two orphan medicines and one biosimilar, at its November 2017 meeting. 10 November 2017
Pharmaceutical
Indian drugmaker Zydus Healthcare today announced that the Mexico regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk), has granted marketing approval to commercialize Lipaglyn (saroglitazar magnesium) in Mexico. 10 November 2017
Biotechnology
The US Food and Drug Administration yesterday granted regular approval for a fourth indication for Adcetris (brentuximab vedotin). 10 November 2017
Biotechnology
Boosted by his firm’s positive Phase III presentation at last week’s ATTR meeting, Alnylam Pharmaceuticals’ EVP of research and development Akshay Vaishnaw won’t commit to saying that regulatory approval is inevitable, but he and president Barry Greene certainly give that impression. 10 November 2017
Pharmaceutical
Simon Stevens, chief executive of National Health Service (NHS) England, called an access agreement struck with German pharma major Merck KGaA over Mavenclad (cladribine) the type of deal that “we would like to see more of”. 9 November 2017
Biosimilars
FDA Commissioner Scott Gottlieb has announced new draft guidance for the pharmaceutical industry affecting Risk Evaluation and Mitigation Strategies (REMS) submissions. 9 November 2017
Pharmaceutical
The US Food and Drug Administration yesterday approved Prevymis (letermovir) tablets and injection, the first drug indicated to help prevent CMV (cytomegalovirus) infection and disease in adults who have been exposed to CMV and have received an allogeneic hematopoietic stem cell (bone marrow) transplant (HSCT). 9 November 2017
Pharmaceutical
Australia’s Therapeutic Good Administration (TGA) has released draft guidance documentation for the Provisional Approval pathway for prescription medicines that is currently being developed in response to recommendations of the Medicines and Medical Devices Regulation Review. 9 November 2017
Pharmaceutical
The Danish Ministry of Interior and Health has announced that the political parties have decided to permanently legalize treatment with medical cannabis in Denmark. 29 November 2024
Pharmaceutical
Industry is showing a very high level of readiness for upcoming new packaging and labelling measures impacting the UK market, according to the Medicines and Healthcare products Regulatory Agency (MHRA). 29 November 2024
Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Pharmaceutical
A new indication for olverembatinib, developed by Suzhou-based Ascentage Pharma will be added to China’s National Reimbursement Drug List (NRDL) from next year. 28 November 2024
Biotechnology
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Pharmaceutical
The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of classic galactosemia, under development by Applied Therapeutics. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm 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
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
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
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
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
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