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
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 BeOne Medicines, formerly 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
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Biotechnology
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
Generics
While likely not the US Food and Drug Administration’s intent, the net effect of the agency’s requirements surrounding importation of active pharmaceutical ingredients (API) is driving manufacturing of investigational finished drug products outside the USA, note David Gibbons and Dara Katcher Levy on Hyman, Phelps & McNamara’s FDA Law Blog. 2 March 2018
Pharmaceutical
The European Medicines Agency (EMA) has taken a step closer to formalizing its move to Amsterdam after accepting the pledge of the Dutch government that its brand new, tailor-made premises will be ready in the city by November 2019. 1 March 2018
Pharmaceutical
Children and rare disease patients could be excluded from lifesaving clinical trials and networks when the UK leaves the European Union, according to the Brexit Health Alliance. 1 March 2018
Pharmaceutical
Investors in Akorn had a wake-up call yesterday, as Germany-based Fresenius raised doubts about its acquisition of Akorn amid a Food and Drug Administration enquiry into alleged allegations of FDA integrity requirements relating to product developments 28 February 2018
Biotechnology
The European Commission has approved Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in people with hemophilia A with factor VIII inhibitors. 28 February 2018
Generics
Continuing its tirade against some developed and developing countries, the US drugmakers lobby group Pharmaceutical Research and Manufacturers of America (PhRMA) has urged the office of the US Trade Representative (USTR) to take immediate action to address serious market access and intellectual property (IP) barriers in 19 overseas markets, including India, reports The Pharma Letter’s India correspondent. 28 February 2018
Pharmaceutical
UK-headquartered Seqirus today announced its intention to commercialize its cell-based quadrivalent flu vaccine (QIVc) in Europe. 28 February 2018
Pharmaceutical
As Rare Disease Day approaches, the US FDA has released a statement outlining steps the agency is taking to promote the development of therapies in this area. 27 February 2018
Pharmaceutical
The newly appointed secretary of the US Health and Human Services (HHS), Alex Azar, has outlined concrete steps his agency plans to take to combat the country’s opioid addiction epidemic. 27 February 2018
Pharmaceutical
Eli Lilly has been granted US FDA approval for Verzenio (abemaciclib) in a new indication, expanding the marketable treatments for the therapy to include initial endocrine-based therapy for certain metastatic breast cancer patients, in combination with an aromatase inhibitor (AI). 27 February 2018
Pharmaceutical
With the USA’s flu epidemic apparently subsiding, the FDA’s Commissioner Scott Gottlieb has provided an update on his agency's efforts to improve the effectiveness of influenza vaccines. 27 February 2018
Pharmaceutical
The Argentinian Administration of Medicines, Food and Medical Technology (ANMAT), has approved the registration of Mavenclad (cladribine tablets) for the treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features. 27 February 2018
Pharmaceutical
The New Drug Application (NDA) for lusutrombopag (S-888711), an investigational, once-daily, orally administered, small molecule thrombopoietin (TPO) receptor agonist, has been accepted for filing and has been granted Priority Review by the US Food and Drug Administration. 27 February 2018
Pharmaceutical
The Russian government plans to start investigation of the activities of some leading domestic and global drugmakers operating in the local market, due to their activities for the prevention of introducing a system of drug labeling in the country, according to recent statements by Russia’s Deputy Prime Minister Igor Shuvalov, reports The Pharma Letter’s Russia correspondent. 26 February 2018
Pharmaceutical
Prodrug specialist KemPharm has announced it has been granted approval for its opioid analgesic Apadaz (benzhydrocodone/acetaminophen) in the USA, sending the firm’s share price up 14%. 26 February 2018
Pharmaceutical
Following litigation over pregabalin’s second-use medical patent for neuropathic pain NHS England were required by the court to instruct GPs to prescribe the branded form (Lyrica) for Pain, notes a new study led by Oxford University researchers and published by BioRxiv. 26 February 2018
Pharmaceutical
Research published in the European Journal of Clinical Pharmacology has shown that the US Food and Drug Administration consistently beats other agencies to the finishing line in approving new drugs. 26 February 2018
Pharmaceutical
By Dr Nicola Davies
In 2009, the US Food and Drug Administration outlined steps to improve its transparency program in three phases.1 26 February 2018
Pharmaceutical
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved single-dose influenza drug Xofluza (baloxavir marboxil) for the treatment of influenza types A and B. 26 February 2018
Biotechnology
Honk Kong-based Golden Meditech, a diversified medtech and healthcare services firm, has acquired licenses to permit genetic testing and cell and tissue storage services in Shanghai. 26 February 2018
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