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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Pharmaceutical
A report concludes that the prospect of leaving the European Union (EU) without an agreement that protects the UK’s pharmaceutical industry would be disastrous for just about everyone with a stake in the sector – from drugmakers to patients. 17 May 2018
Biotechnology
The European Commission (EC) has approved a new indication in the Repatha (evolocumab) label for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol (LDL-C) levels. 17 May 2018
Biosimilars
US pharma giant Pfizer has advanced its number of approved biosimilar medicines in the USA to three. 16 May 2018
Pharmaceutical
The US Food and Drug Administration (FDA) wants to bring clarity and efficiency to combination product regulation, the agency has announced. 16 May 2018
Pharmaceutical
The USA-based non-profit Institute for Patient Access (IfPA) has released the results of a recent poll of physicians showing concern about the federal government’s 340B drug pricing program, which was designed to encourage care for indigent and underinsured patients but has instead ballooned into a revenue stream for growing hospital systems. 16 May 2018
Pharmaceutical
On Monday, Health and Human Service Secretary Alex Azar delivered remarks on President Trump's blueprint to bring down the high price of prescription drugs and put American patients first. 15 May 2018
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued its Final Appraisal Determination (FAD) recommending the use of four out of six disease-modifying therapies in relapsing-remitting multiple sclerosis. 14 May 2018
Pharmaceutical
The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Briviact (brivaracetam) CV oral formulations indicated as monotherapy and adjunctive therapy in the treatment of partial onset (focal) seizures in patients age four years and older. 14 May 2018
Biosimilars
As a result of biosimilars slow entry into the US market, the Food and Drug Administration is taking proactive measures to ensure the continued growth of the biosimilars market by educating patients and physicians through online resources and information campaigns to encourage more competition and lowered prices of biologics. 14 May 2018
Biotechnology
On Friday, US President Donald Trump announced his much awaited plans for lowering the prices of medicines, which require Medicare Part D plans to share a portion of discounts they receive from drug manufacturers with patients, as well as including ways to allow the government to better negotiate prices. 12 May 2018
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Gilenya (fingolimod) for the treatment of children and adolescents 10 to less than 18 years of age with relapsing forms of multiple sclerosis (RMS), making it the first disease-modifying therapy indicated for these patients. 12 May 2018
Biotechnology
Safety concerns could not stop the majority of a US Food and Drug Administration (FDA) committee voting in favor of approving volanesorsen for familial chylomicronemia syndrome (FCS), a rare lipid disorder with no therapeutic options. 11 May 2018
Pharmaceutical
In the two years since its launch, the PRIority Medicines scheme (PRIME) of the European Medicines Agency (EMA) has succeeded in driving innovation and improved the efficiency of the development process in therapeutic areas with the most pressing unmet medical needs. 11 May 2018
Pharmaceutical
The Drugs Controller General of India (DCGI) and the Indian Council of Medical Research (ICMR) have come under fire for approving the human papillomavirus (HPV) vaccine for cervical cancer patients, despite a report by India's Parliament opposing its use. The government, meantime, continues to dither over introducing the HPV vaccine in its Universal Immunization Program, reports The Pharma Letter’s India correspondent. 10 May 2018
Pharmaceutical
Chinese pharma development firm WuXi STA has announced that its newly-built facility in Changzhou has received perfect feedback from the US Food and Drug Administration (FDA) in its inaugural inspection. 9 May 2018
Pharmaceutical
Shares of US drugmaker Lipocine tumbled more than 32% to $1.20 in premarket trading today, after the company revealed that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration. 9 May 2018
Pharmaceutical
A leading trade group representing the pharmacy benefit manager (PBM) industry in the USA has responded to a report from the American Diabetes Association (ADA), which it says “confirms that drugmakers set, and continue to raise, prices.” 9 May 2018
Pharmaceutical
Australia’s Federal Budget has revealed a comprehensive plan for ‘better targeting the research and development tax incentive’ (R&DTI). 9 May 2018
Pharmaceutical
A ‘global revolution’ must occur in new cancer drug pricing if the world is to cope with the growing instances of the disease. 8 May 2018
Biotechnology
Darzalex (daratumumab) is the first monoclonal antibody to receive US Food and Drug Administration approval to treat multiple myeloma and reached blockbuster status in 2017. 8 May 2018
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
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