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.
India’s Sun Pharmaceutical Industries says that its US subsidiary is voluntarily recalling two lots of Riomet (metformin hydrochloride oral solution), 500mg/5mL, to the retail level (Class II Recall). 25 November 2017
Local Israeli press are reporting that Teva Pharmaceutical Industries is about to cut a fifth of its global workforce of nearly 60,000, mostly in the USA. 23 November 2017
US FDA commissioner Scott Gottlieb has announced new measures to promote the development of generic abuse-deterrent formulation opioids. 22 November 2017
The US Food and Drug Administration has started including patent submission dates in the so-called Orange Book, the record of approved drug products. 22 November 2017
Taipei-based generics maker TWi Pharmaceuticals has bought Synpac-Kingdom Pharmaceutical (SKP), another generics supplier known for ophthalmic treatments, for NT$1.8 billion ($59.8 million), reports The Pharma Letter’s China correspondent Wang Fangqing. 17 November 2017
US generic drugmaker KVK Tech has entered into a strategic partnership with Productos Medix, a leader in pharmaceutical obesity products in Mexico. 15 November 2017
Japanese drugmaker Sawai Pharmaceutical will sell a 20% stake in its US subsidiary (Sawai America) to Sumitomo Corporation of Americas (SCOA), a subsidiary of Sumitomo Corporation, one of Japan's leading general trading houses. 13 November 2017
US pharma giant Pfizer revealed on Friday that it has sold its 49% equity share in its joint venture, Hisun-Pfizer Pharmaceutical to Sapphire (HK) Holdings Limited. 13 November 2017
Indian pharma major Lupin has suffered a major drop in share price after the US FDA issued the firm with a warning letter related to two of its manufacturing sites. 8 November 2017
Netherlands-incorporated generics major Mylan saw its shares rise 0.9% to $36.40 in late-morning trading, have hit a $36.92 pre-market after posting third-quarter 2017 financials that came in below analysts’ forecasts. 6 November 2017
The first job of Kåre Schultz, the new president chief executive of Teva Pharmaceutical Industries, will be to pick the company off the floor after another disastrous set of financial results and subsequent stock market pounding. 2 November 2017
Indian generic drugmaker Alembic Pharmaceuticals has completed a buy of a New-Jersey based company that takes its number of abbreviated new drug application (ANDA) approvals in the USA to 69. 1 November 2017
Attorneys general from 45 states in the USA have widened the scope of an earlier court action which alleges collusion to fix generic drug prices. 1 November 2017
Ireland-incorporated Endo International has revealed that two of its subsidiaries have filed suit in the US District Court for the District of Columbia against the Food and Drug Administration. 31 October 2017
Israel’s Teva Pharmaceutical Industries today announced that Kåre Schultz will join the company as president and chief executive, effective November 1, 2017. 31 October 2017
Amid falling sales of its leading diabetes product Lantus (insulin glargine) due to generic competition, French pharma major Sanofi is taking further legal action in the USA. 25 October 2017
The lower cost of developing generics is one factor driving increased interest in the sale of branded generics products on the part of innovative drugmakers. 24 October 2017
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.