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
Pharmaceutical
US Food and Drug Administration Commissioner Scott Gottlieb has welcomed the White House budget request of $5.8 billion for the agency in 2019, an increase of 13% from this year. 18 April 2018
Biotechnology
Shares in Californian biotech Rigel Pharmaceuticals (Nasdaq:RIGL) leapt a tenth yesterday on news that the US regulator had approved Tavalisse (fostamatinib disodium hexahydrate) to treat adult patients with chronic immune thrombocytopenia (ITP). 18 April 2018
Biotechnology
The US Food and Drug Administration has approved Crysvita (burosumab), the first drug cleared to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets. 18 April 2018
Biotechnology
UK-based cannabinoid specialist GW Pharmaceuticals was up by a double-digit percentage by Tuesday afternoon as investors looked at the latest news on its New Drug Application for Epidiolex (cannabidiol or CBD). 17 April 2018
Biotechnology
Analysts at Jeffries have predicted that Roche’s Hemlibra (emicizumab) could generate $5 billion in annual sales – provided its use for hemophilia A is widened to the larger, non-inhibitor population. 17 April 2018
Biotechnology
The combination of Opdivo (nivolumab) 3mg/kg plus Yervoy (ipilimumab) 1mg/kg (injections for intravenous use) has received priority approval from the US Food and Drug Administration as the first immuno-oncology combination therapy for previously untreated patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC). 17 April 2018
Biotechnology
It is not uncommon for drugmakers to imply that mistaken regulatory staff or a misunderstanding are the reason for development setbacks. 16 April 2018
Biotechnology
The Australian government will drastically reduce the cost of a life-saving new medicine, which uses a patient’s own immune system to track down and destroy cancer cells. 16 April 2018
Pharmaceutical
A report from market analyst GlobalData finds that the Chinese pharmaceutical market is expected to grow at an annual rate of 30% up to 2022, pushing the size of the market up to $573 billion. 16 April 2018
Biotechnology
The US Food and Drug Administration has lifted the clinical hold on studies of BPX-501 in the USA. 14 April 2018
Biotechnology
Massachusetts, USA-based messenger RNA (mRNA) specialist Translate Bio says the US Food and Drug Administration has cleared the company to begin a first-in-human clinical trial of MRT5005 in patients with cystic fibrosis. 13 April 2018
Pharmaceutical
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has released highlights from its meeting that took place April 9-12. 13 April 2018
Pharmaceutical
A study published by an American Society of Clinical Oncology (ASCO) journal has concluded that improvements in the clinical benefits of cancer drugs have come at a slower pace than rises in their price. 13 April 2018
Biotechnology
A draft report into the hotly-anticipated development area of CGRP inhibitors has been released by US cost-effectiveness watchdog the Institute for Clinical and Economic Review (ICER). 13 April 2018
Biotechnology
Insurers denied coverage for nearly 80,000 patient claims for cholesterol-lowering drugs known as PCSK9 inhibitors in 2017, according to new findings. 12 April 2018
Generics
The European Medicines Agency and its European and international partners have successfully strengthened their interactions to improve the oversight of active pharmaceutical ingredient (API) manufacturers worldwide, as highlighted in the International API inspection program report for 2011-2016, published today. 12 April 2018
Pharmaceutical
More drug approvals, a busy US Food and Drug Administration (FDA) and the growing success of small and medium sized pharma companies are some of the major findings of a comparison published on Thursday. 12 April 2018
Biotechnology
The US Food and Drug Administration has said that it requires extended time to review additional information regarding the results of liver function tests provided in connection with its New Drug Application (NDA) for elagolix in endometriosis-associated pain. 12 April 2018
Generics
While the ongoing trade war between the USA and China will have huge ramifications on the biopharmaceutical industry for both countries, it appears that China is in a much better position from a negotiation standpoint, according to analysts. 12 April 2018
Pharmaceutical
The Drugs for Neglected Diseases initiative (DNDi) says results from its Phase II/III STORM-C-1 trial of a sofosbuvir/ravidasvir combination produced by Egyptian generic drugmaker Pharco Pharmaceuticals, shows the hepatitis C therapy to be “safe and effective, with extremely high cure rates for patients, including hard-to-treat cases.” 12 April 2018
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