3 October 2024 F2G’s September $100m funding round provides the company with crucial funds to
renavigate approval of its lead drug, olorofim. The substantial financing also
highlights the paucity of novel antifungal products in the clinic.
Aspire Pharma, a UK-based niche generics business, has announced the acquisition of all assets from Canute Pharma, further expanding its product range. 4 October 2024
US antivirals giant Gilead Sciences today announced that it has signed non-exclusive, royalty-free voluntary licensing agreements with six generic drugmakers to make and sell generic lenacapavir 2 October 2024
The US Food and Drug Administration (FDA) yesterday released its fiscal year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Outcomes Report. 2 October 2024
The number of clinical trials of new drugs in Russia is steadily declining, which could be mainly related with the overall reduction of investment activities in the local pharmaceutical market, reports The Pharma Letter’s local correspondent. 30 September 2024
The generics and biosimilars trade group, Medicines for Europe, has put out a strong message amid ongoing discussions on a European Union (EU) Critical Medicines Act. 26 September 2024
The protection of intellectual property (IP) rights of foreign pharmaceutical companies in Russia remains complex situation, according to recent statements by Konstantin Panurovsky, legal director of AstraZeneca’s Russian subsidiary, reports The Pharma Letter’s local correspondent. 13 September 2024
The US Food and Drug Administration (FDA) yesterday announced revised final guidance for industry entitled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.” 12 September 2024
Several pharma companies that had moved the Delhi High Court against the government’s recent notification banning 156 fixed-dose combination (FDC) drugs have got a breather. 10 September 2024
A significant drop has been noticed in the prices of active pharmaceutical ingredients (APIs), bringing much-needed relief to the pharmaceutical industry and potentially translating to lower drug costs for consumers. 9 September 2024
Glenmark Pharmaceuticals has agreed to pay $25 million, based on its ability to pay, to resolve its alleged liability under the False Claims Act for conspiring to fix the price of a generic drug, the US Department of Justice announced. 5 September 2024
German pharma major Bayer has filed a lawsuit against the Russian drugmaker Promomed to protect the patent rights for Xarelto (rivaroxaban), its treatment for stroke prevention which is the best-selling drug in the Russian market at present, The Pharma Letter’s local correspondent reports. 2 September 2024
German generics major STADA Arzneimittel today announced that it achieved sales of more than 2 billion euros ($2.23 billion) in the first half of 2024. 28 August 2024
In a major crackdown, the Indian government has imposed an immediate ban on 156 fixed-dose combination (FDC) drugs, including commonly used antibiotics, pain relievers,and multivitamins. 27 August 2024
Swipha, a leading Nigerian pharmaceutical manufacturer, has received prequalification from the World Health Organization (WHO) for its sulfadoxine-pyrimethamine (SP) drug. 21 August 2024
One of the largest pharmaceutical production facilities in the Russian North-West region will soon be built in the city of Pushkino by the local drugmaker Active Component enterprise, The Pharma Letter’s local correspondent reports. 14 August 2024
Even as Novartis (NOVN: VX) is locked in a high-stakes battle with the US Food and Drug Administration (FDA) to protect its blockbuster heart failure drug Entresto (sacubitril and valsartan) from generic competition, generic versions of valsartan are making hay in India 8 August 2024
The Russian Ministry of Health has registered the third Russian generic of the original drug Ozempic (semaglutide) from Danish drugmaker Novo Nordisk. 8 August 2024
US biotech major Biogen is disputing the launch of a Russian generic of Spinraza (nusinersen), a drug, which is used to treat spinal muscular atrophy (SMA), reports The Pharma Letter’s local correspondent. 7 August 2024
Imports of bulk drugs from China have jumped, potentially undermining India's efforts to boost domestic pharmaceutical manufacturing through its Production Linked Incentive (PLI) scheme. 5 August 2024
US healt hcare company Abbott on Wednesday reported second-quarter results ahead of estimates boosted by strong sales in its branded generics business. The company reported net sales of $5.17 billion up 2% year on year. 22 July 2015
Indian pharma companies may finally be looking at a better rate of clearances from the US Food and Drug Administration as the third year of GDUFA (Generic Drug User Fee Amendment of 2012) draws to a close. 22 July 2015
Middle-income countries will be home to 70% of people living with HIV by 2020 but face increasing threats to their ability to access affordable generic medicines, warned Médecins Sans Frontières (MSF) at the International AIDS Society (IAS) Conference. 22 July 2015
Sun Pharmaceutical on Wednesday rebounded from over 15% plunge after the company said Tuesday it sees flat sales in fiscal 2016. India’s largest drugmaker by market value said the cost of integrating Ranbaxy will impact revenue and profits in 2016. 22 July 2015
Demeke Mekonnen, Deputy Prime Minister of Ethiopia, last week launched an ambitious 10-year national strategy and plan of action to develop local pharmaceutical manufacturing capacity in order to increase access to locally manufactured, quality-assured, medicines. 20 July 2015
Biosimilar injectables specialist Hospira has obtained approval from the US Food and Drug Administration for bivalirudin, a generic of Angiomax from The Medicines Company. 17 July 2015
Albany Molecular Research says it has acquired all the outstanding shares of Gadea Pharmaceutical, a privately-held company located in Valladolid, Spain. 16 July 2015
The US Food and Drug Administration on Tuesday banned drug imports from Emcure Pharmaceuticals' India-based plant following an investigation that revealed violation of standard manufacturing practices. 15 July 2015
The European Medicines Agency has released for consultation product-specific guidance on bioequivalence studies for four active substances. 15 July 2015
Israel-based generics giant Teva Pharmaceutical Industries has launched its generic version of the migraine drug Axert (almotriptan malate) tablets in the USA. 9 July 2015
According to sources close to the matter, Israel-based Teva Pharmaceutical Industries is considering upping its offer to buy US generic drugmaker Mylan by as much as $2 billion. 7 July 2015
The Pharmaceutical Manufacturers Association of Nigeria (PMGMAN) has raised concerns over the New Drug Distribution Guideline, NDDG, and Common External Tariff (CET), saying that they are threats to the survival of the local pharmaceutical industry, reports the local Vanguard newspaper. 7 July 2015
A Russian pharmaceutical delegation, composed of over 50 representatives from more than 20 companies and led by Sergey Tsyb, the deputy director of the Ministry of Industrial and Trade of Russia, attended the recent 2015 CPhI China for the first time. 6 July 2015
Indian drugmaker Lupin (BSE: 500257) has announced a second acquisition in the last couple months, this time taking a 100% equity stake in ZAO Biocom in Russia subject to certain closing conditions. 3 July 2015
The Medicines Patent Pool (MPP) has made a rapid expansion of its network of generic manufacturers to 14, now working no more than 50 projects to develop MPP-licensed antiretrovirals. 2 July 2015
Indian drugmaker Marksans Pharma has acquired USA-based Time-Cap Laboratories for an undisclosed amount, according to Indian media reports. 2 July 2015
Israel-based Teva Pharmaceutical Industries today announced the launch of a generic version Aggrenox (aspirin/extended-release dipyridamole) capsules in the USA. 1 July 2015
Several complaints that manufactures in India are selling life saving anticancer drugs at exorbitant prices has got the drug regulator to pressurize the National Pharmaceutical Pricing Authority (NPPA) to include anticancer drugs under the Drug Price Control Order (DPCO), reports The Pharma Letter’s India correspondent. 29 June 2015
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A pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases.