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.
The Indian pharmaceutical market is expected to be worth $55 billion by 2020, becoming the sixth largest market in the world, according to India's Ambassador to the USA, Shri Arun Singh who inaugurated the 34th annual convention of American Association of Physicians of Indian Origin in New York recently. 5 July 2016
After decades of manufacturing generics, China is eager to catch up with novel drug development for further growth, says The Pharma Letter’s local correspondent Wang Fangqing. 4 July 2016
Earlier this week, iPR Pharmaceuticals, the owner of NDA 021366 for Crestor (rosuvastatin calcium) and Anglo-Swedish pharma major AstraZeneca (LSE: AZN), which markets the cholesterol drug, filed a Complaint a in the US District Court for the District of Columbia seeking to block the US Food and Drug Administration’s approval of Abbreviated New Drug Applications (ANDAs) for generic Crestor tablets. 30 June 2016
Australia's Mayne Pharma has propelled itself into one of the top 25 generics sellers in the USA by joining in the buy-up of assets from Israel’s Teva Pharmaceutical Industries and Ireland-incorporated Allergan. 29 June 2016
At its June meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of six new medicines, including one advanced therapy medicinal product (ATMP). 25 June 2016
Teva Pharmaceutical Industries plans to double the volume of production at its pharmaceutical factory in Russia’s Yaroslavl up to 500 million tablets per year, compared to the current 250 million, according to recent statements of the Yaroslavl regional authorities. 25 June 2016
The US subsidiary of Israeli generics major Teva Pharmaceutical Industries (NYSE: TEVA) has reach a patent settlement agreement with AstraZeneca, its subsidiaries and Amylin Pharmaceuticals relating to the Anglo-Swedish pharma major’s patents on Byetta (exenatide). 23 June 2016
USA-based Impax Laboratories has become the latest company to buy up assets being sold by Israeli generics giant Teva Pharmaceutical Industries in a $586 million deal. 21 June 2016
Russia’s National Immunobiological Company (Nacimbio; state corporation Rostec) together with Cipla, during SPIEF’16 signed a Memorandum of Understanding (MoU) on innovative antiviral medical products for HIV and hepatitis C treatment and on technology transfer and active pharmaceutical ingredients (API) manufacturing. 21 June 2016
India’s Zydus Cadila has added to its US portfolio by buying two new Abbreviated New Drug Applications (ANDAs) from Israeli generics giant Teva Pharmaceutical Industries in an undisclosed transaction. 20 June 2016
Export of pharmaceutical products from India is likely to exceed the $14 billion mark this year and may reach about $20 billion by 2020, thereby registering a compounded annual growth rate (CAGR) of about 8%, according to an Associated Chambers of Commerce & Industry of India (ASSOCHAM)-TechSci Research joint study. 20 June 2016
US specialty drugmaker Sagent Pharmaceuticals has agreed to buy five products being developed by Israeli generics giant Teva Pharmaceutical Industries. 17 June 2016
Beximco has notched up another milestone by becoming the first Bangladeshi pharma company to launch pharmaceutical products in any Gulf member country by starting to export to Kuwait. 17 June 2016
The global generic drugs market 2016 report forecasts patent expiry of drugs worth $150 billion by 2020, which a key growth driver for top-selling drugs as well as new, inexpensive generic drugs. 16 June 2016
The US Senate Judiciary Committee introduced new legislation Tuesday, aimed at countering the growing issue of rising prescription drug prices in the USA and anti-competitive moves by pharmaceutical companies to delay lower-priced generic competition from entering the market. 15 June 2016
Drug pricing was on Wall Street’s mind again Friday, as Wells Fargo tapped Netherlands-incorporated Mylan as the next target for activists, reported Investor’s Business Daily. 13 June 2016
India’s Dr Reddy’s Laboratories has entered into a definitive agreement with Teva Pharmaceutical Industries and an affiliate of Allergan to acquire a portfolio of eight Abbreviated New Drug Applications (ANDAs) in the USA for $350 million in cash at closing. 13 June 2016
There is an urgent need for renewal of Written Confirmation (WCs) issued by the Drug Controller General of India (DCGI) for active pharmaceutical ingredient (API) exporters to the European Union, according to Brand India Pharma. 9 June 2016
Sun Pharma says that, as a part of its manufacturing consolidation in the USA, one of its wholly owned subsidiaries has entered into an agreement with Frontida BioPharm for the divestment of its two oral solid dosage manufacturing facilities. 6 June 2016
The UK’s Competition and Markets Authority (CMA) has told The Pharma Letter that it continues to investigate suspected excessive pricing in the pharmaceutical industry. 3 June 2016
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
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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.