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
Today's issue
Refine Search
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
Biosimilars
The group representing generic and biosimilar drugmakers across Europe has published a new report reviewing the policies supporting the new wave of copycat treatments that could create access to biologics that are out of reach for many patients. 12 September 2017
Biotechnology
With US approval expected to be granted within months for emicizumab, a monoclonal antibody currently under review for the prevention of bleeding in patients who have hemophilia A with factor VIII inhibitors, another question is looming large – how much is it worth? 12 September 2017
Biosimilars
Privately-held USA-based Adello Biologics has had its Biologics License Application (BLA) for a biosimilar candidate referencing Neupogen (filgrastim) accepted for review by the US Food and Drug Administration (FDA). 12 September 2017
Biosimilars
The US Food and Drug Administration has accepted a Biologics License Application (BLA) under the 351 (k) pathway for a proposed biosimilar to the reference medicine, Rituxan (rituximab) from Sandoz. 12 September 2017
Pharmaceutical
From December 1, 2017, approved suppliers will be required to enter a Compounder ID when submitting claims for eligible Australia’s Prescription Benefits Scheme (PBS) efficient funding of chemotherapy claims (EFC) items through PBS Online. Claims submitted without a compounder ID will not be paid, the country’s health regulator has announced. 11 September 2017
Pharmaceutical
UK pharma major GlaxoSmithKline has announced that Menveo (meningococcal ACWY oligosaccharide conjugate vaccine) has received Therapeutics Goods Administration (TGA) approval for use in younger age groups in Australia. 11 September 2017
Pharmaceutical
The Pharmaceutical Manufacturers Group of the Manufacturers Association of Nigeria (PMGMAN) has expressed optimism that the recent Executive Orders given by Vice President Yemi Osinbajo on the Support for Local Content in Public Procurement will lead to export of Nigerian medicines abroad, according to a report by Martins Ifjeh in This Day newspaper. 11 September 2017
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has published draft guidance recommending Xeljanz (tofacitinib) for some people with rheumatoid arthritis (RA). 8 September 2017
Generics
Biocon’s subsidiary in Malaysia, Biocon Sdn Bhd, has been issued a certificate of ´GMP Compliance´ for its insulins manufacturing facility by the HPRA (Ireland) as the representative European Union inspection authority. 8 September 2017
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation status to cemiplimab (REGN2810) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC, the second deadliest skin cancer after melanoma. 8 September 2017
Generics
Genentech, a subsidiary of Swiss pharma giant Roche, is voluntarily recalling three lots of Activase (alteplase) 100mg vials, that were co-packaged with Sterile Water for Injection, to the hospital level. 8 September 2017
Biotechnology
Risks identified with using Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for multiple myeloma patients have emerged as bad news not just for the rights holder to that drug, Merck & Co. 7 September 2017
Pharmaceutical
Responding to the publication of the UK government position paper on science and innovation post-Brexit - Life Sciences Industrial Strategy, Elisabethann Wright, a partner at law firm Hogan Lovells, said: “Much of the focus in the paper is on current relationships between researchers in the UK and other EU member states which will hopefully continue after Brexit. However, the paper also discusses possible future bilateral relationships. 7 September 2017
Biotechnology
Chicago, USA-based AbbVie has filed for regulatory approval in the USA for elagolix, an investigational therapy for endometriosis-associated pain, under development in collaboration with Neurocrine Biosciences. 7 September 2017
Biotechnology
The US Food and Drug Administration has placed a partial clinical hold on CA209602 (CheckMate-602), CA209039 (CheckMate-039) and CA204142, three clinical trials investigating Opdivo (nivolumab)-based combinations in patients with relapsed or refractory multiple myeloma. 7 September 2017
Biotechnology
UK medicines cost effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has issued final technology appraisal guidance recommending the use of Abraxane (nab paclitaxel) in combination with gemcitabine, in eligible patients, for the first-line treatment of a type of metastatic pancreatic cancer, known as metastatic pancreatic ductal adenocarcinoma (mPDAC). 7 September 2017
Pharmaceutical
The US Food and Drug Administration is recommending that patients avoid taking the potassium-lowering drug sodium polystyrene sulfonate (Kayexalate, from Concordia Healthcare) at the same time as any other medicines taken by mouth. 7 September 2017
Biotechnology
The death of the very first patient treated has forced Cellectis to stop running its two Phase I trials of a gene edited ‘off-the-shelf’ immunotherapy, sending the France-based company’s share price plummeting by more than 20% on Tuesday. 6 September 2017
Pharmaceutical
Novo Nordisk will pay $58.65 million to resolve allegations that the company failed to comply with the Food and Drug Administration-mandated Risk Evaluation and Mitigation Strategy (REMS) for its top-selling type 2 diabetes medication Victoza (liraglutide), the Justice Department announced yesterday. 6 September 2017
Generics
A new study “Value Added Medicines: Time to Adjust the HTA Decision Frameworks” was launched today in Brussels with the support of the Value Added Medicines Group, a sector group of Medicines for Europe. 6 September 2017
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze