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
Ahead of World Hepatitis Day on July 28, the Indian government is to give away free antiviral for hepatitis C to tackle liver cancer. With $87.50 million approved for the current financial year, the government is all set to launch an ambitious National Viral Hepatitis Control Program, reports The Pharma Letter’s India correspondent. 29 July 2018
Janssen Pharmaceuticals, part of US health care giant Johnson & Johnson, is considering initiating legal proceedings against Russian drugmaker Pharmsyntez for the registration of an analogue of an anti-HIV rilpivirine drug, the patent for which belongs to Janssen, reports The Pharma Letter’s local correspondent. 24 July 2018
Indian pharma major Lupin saw its shares fall 3.75% to 833.15 rupees this morning despite announcing that it has received approval from the UK health regulator for its Goa manufacturing facility. 16 July 2018
On Friday, the US Food and Drug Administration alerted health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. 16 July 2018
Like other victims of a toxic US political environment, Obama-era FDA pick Robert Califf did not long survive the political turbulence of presidential election season. 11 July 2018
Tamoxifen, the billion-dollar breast cancer generic, has been revealed to cause higher rates of womb cancer in patients, according to a study published in the British Journal of Surgery (BJS). 9 July 2018
The European Medicines Agency (EMA) is reviewing medicines containing the active substance valsartan that is supplied by Zhejiang Huahai Pharmaceuticals, a company based in Linhai, China. 6 July 2018
Having announced in April that it is discussing the sale of Zentiva, French pharma major Sanofi says it has now concluded negotiations for the acquisition of its European generics business, by Advent International. 28 June 2018
Eli Lilly on Friday announced that the US District Court for the Southern District of Indiana ruled in favor of Lilly that the Alimta (pemetrexed for injection) vitamin regimen patent would be infringed by a competitor that had stated its intent to market alternative salt forms of pemetrexed prior to the patent's expiration in
2022. 23 June 2018
US Food and Drug Administration Commissioner Scott Gottlieb has outlined plans for two new initiatives to modernize aspects of the generic drug review process. 19 June 2018
A Russian pharmaceutical company for the first time has received a license for the production an analogue of a drug in Russia, the rights for which are owned by a global drugmaker, reports The Pharma Letter local correspondent. 15 June 2018
The US Food and Drug Administration on Thursday approved the first generic versions of Indivior’s top-selling opioid addiction treatment Suboxone (buprenorphine and naloxone) sublingual film for the treatment of opioid dependence. 15 June 2018
Some two-and-a-half years after receiving a warning letter from the US Food and Drug Administration (FDA) about its manufacturing practices, India's biggest drugmaker has stated that the agency is now satisfied that the issues have been addressed. 13 June 2018
Indian pharma majors selling copycat drugs in the USA are facing the heat given the steep competition and pricing pressure, and President Donald Trump's new policy on lowering drug prices, reports The Pharma Letter’s India correspondent. 12 June 2018
The UK’s National Audit Office (NAO) is investigating unexpected rises in the prices of certain generic medicines bought by pharmacies for the National Health Service (NHS) last year, it was announced on Friday. 8 June 2018
As part of its efforts to promote the use of generics in the US healthcare system, the Food and Drug Administration has released a document outlining what it believes are the cost-savings associated with the use of copycat drugs approved last year. 7 June 2018
In a May 31 statement, US Food and Drug Administration Commissioner Scott Gottlieb said the agency was reforming its regulations around the Risk Evaluation and Mitigation Strategy (REMS), a method for pharmaceutical companies to control the distribution of drugs that have serious risks and balance drug benefits with hazards. 1 June 2018
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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.