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
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
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
Pharmaceutical
Attempts to reassure investors by the chief executive of AcelRx Pharmaceuticals could not stop the share price of the USA-based specialty pharma company from falling off a cliff on Thursday. 13 October 2017
Pharmaceutical
Following the Republican party's failure to repeal the Affordable Care Act, US President Donald Trump went it alone Thursday, signing a heavily-trailed executive order that could scupper the legislation. 13 October 2017
Biotechnology
A unanimous vote by a US Food and Drug Administration (FDA) advisory committee on Thursday has put a Philadelphia-based biotech in pole position to reach market with the USA’s first gene therapy for a genetic disease. 13 October 2017
Pharmaceutical
The key drivers for the Indonesian pharmaceutical market are the introduction of 15 economic policy packages to attract foreign investors, the implementation of Universal Health Coverage scheme (Jaminan Kesehatan Nasional, JKN), and growing urban population. 13 October 2017
Pharmaceutical
US pharma giant Pfizer received good news today, when the US Food and Drug Administration granted approval for a new formulation of its top-selling drug Lyrica (pregabalin), which in December next year is facing patent expiry. 12 October 2017
Pharmaceutical
Eye disease specialist Aerie Pharmaceuticals has jumped 15% on the Nasdaq, after the US FDA released documents, ahead of an advisory meeting, in which Rhopressa was deemed able to effectively reduce eye pressure. 12 October 2017
Biotechnology
The US Food and Drug Administration has licensed the first monoclonal antibody (MAb) drug substance at its second plant, the world's largest single plant, operated by Samsung BioLogics, a contract manufacturer of biologic drugs under South Korea’s Samsung Group, in Songdo, Incheon. 12 October 2017
Pharmaceutical
Ardelyx has released positive Phase III data from T3MPO-2, the firm’s second Phase III trial of tenapanor for irritable bowel syndrome with constipation (IBS-C). 12 October 2017
Pharmaceutical
The UK’s National Institute for Health and Clinical Excellence (NICE) has today given a positive recommendation for Stivarga (regorafenib). 12 October 2017
Pharmaceutical
In early 2016, the USA’s Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to test new models for the payment of drugs and biologics under Medicare Part B, according to McKenzie Cato and David Gibbons writing on Hyman, Phelps & McNamara on its FDA Law Bog. 11 October 2017
Biotechnology
Drug pricing, subject of impassioned presidential Tweets not so long ago, has ceded priority in recent months, amid the furore over Obamacare replacement efforts. 10 October 2017
Biotechnology
Shares of Poland’s largest biotech firm Selvita plunged 17.2% to 45.12 zlotys on Monday, after the company revealed receipt of a clinical hold on the development of its acute myeloid leukemia (AML) drug by the US regulator. 10 October 2017
Biotechnology
The US Food and Drug Administration has accepted for review the supplemental Biologics License Application (sBLA) for Prolia (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP). 10 October 2017
Pharmaceutical
US president Donald Trump has changed his mind about the value of the executive order. 9 October 2017
Pharmaceutical
The China Food and Drug Administration has announced far-reaching reforms to its regulatory system, that are expected to speed up approvals of medical technologies in the country. 9 October 2017
Pharmaceutical
The European Medicines Agency and the European Commission have updated the annex to the EC guideline on excipients on the labelling and package leaflet of medicinal products for human use. 9 October 2017
Biotechnology
Shares in AstraZeneca edged higher in early dealing today, on the news that US regulators have granted its Tagrisso (osimertinib) Breakthrough Therapy designation and its European peer has accepted the marketing application for its Imfinzi (durvalumab). 9 October 2017
Pharmaceutical
The level of rebates and claw-backs that pharmaceutical companies in Greece are required to pay is unique by European standards and indicative of the over-taxation that is killing the industry. 9 October 2017
Pharmaceutical
The packaging of prescription-only medicinal products must have safety features from February 9, 2019 onwards, the Dutch Medicines Evaluation Board (CBG) has reminded players. 9 October 2017
Biotechnology
By 2050, the world’s population aged 60 years and older is expected to reach 2 billion – a vast leap from the 900 million elderly citizens living across the globe today. 7 October 2017
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