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.
Israel-based Teva Pharmaceutical Industries, say that, despite its recent denials of a rift with its chief executive, its board of directors has agreed with Jeremy Levin that he will step down as president and CEO, just 18 months after assuming the positions at Teva, the world’s largest generics firm. 30 October 2013
South Africa’s National Association of Pharmaceutical Manufacturers (NAPM) held a workshop for health care practitioners at the Johannesburg Country Club earlier this month, titled Generics, Get the Facts Straight. 29 October 2013
US generics major Actavis has reported a net revenue increase of 57% to $2.01 billion for the third quarter 2013, compared with the like 2012 period, along with strong profit growth. 29 October 2013
The Budget Bureau of Japan’s Ministry of Finance, in a meeting of the Fiscal System Council last week, criticized the Ministry of Health, Labor and Welfare for poor control of medical expenditure, reports The Pharma Letter’s local analyst. 29 October 2013
A subcommittee of Japan’s Central Social Insurance Medical Council looked at the effect of the April 2012 revision to the Medical Fee System, resulting in evidence of greater use of generic medicines. 15 October 2013
Teva Pharmaceutical Industries says that the US Food and Drug Administration has granted approval of the generic equivalent to cystic fibrosis drug TOBI (tobramycin inhalation solution USP) in the USA. 14 October 2013
In a filing with the US Stock Exchange Commission, USA-based niche generics firm Akorn announced that it, and takeover target Hi-Tech Pharmacal, as expected, had each received a request for additional information (commonly referred to as a “second request”) from the US Federal Trade Commission in connection with the proposed merger transaction. 13 October 2013
US specialty pharma firm Acura Pharmaceuticals saw its shares leap as much as 28% after it said that it has entered into distinct settlement agreements with each of Par Pharmaceutical and Impax Laboratories to settle Acura's patent infringement action pending against them in the US District Court for the District of Delaware. 11 October 2013
Brazil has emerged as a manufacturing hub for pharmaceutical and biotechnology companies, with the pharma market forecast to grow from $12.4 billion in 2007 to $58.8 billion in 2020, according to GlobalData. 11 October 2013
Israel-based Teva Pharmaceutical Industries, the world’s largest generic drugmaker, says it is taking steps to accelerate the reduction of costs and to optimize its structure and processes. 10 October 2013
Actavis has filed an Abbreviated New Drug Application with the US Food and Drug Administration for buprenorphine hydrochloride and naloxone HCl sublingual film, a generic version of Reckitt Benckiser's Suboxone. 9 October 2013
Elite Pharmaceuticals (OTCBB: ELTP) has signed a manufacturing and license agreement with fellow USA-based, privately held Epic Pharma, granting the latter the right to manufacture, market and sell 12 generic products in the USA and Puerto Rico. 8 October 2013
The District Court of the Hague has issued a favorable ruling for Teva Pharmaceutical Industries in a patent revocation action brought by Mylan seeking a court judgment that Teva’s patent for its Copaxone is invalid. 4 October 2013
The growing prevalence of chronic diseases and an increasing elderly population will boost the Greek pharmaceutical market, which will increase from around $7.8 billion in 2013 to $8.2 billion in 2020, at a compound annual growth rate of 0.6%, forecasts research and consulting firm GlobalData. 4 October 2013
In South Africa, a switch of 5% of the volume of branded medicines to a generic equivalent could save the health care industry and patients in excess of 400 million rand ($39.7 million) per year, says NAPM. 2 October 2013
Mylan says it has launched voriconazole for oral suspension, which is the first generic version of Pfizer's Vfend, a triazole antifungal drug. 30 September 2013
Actavis has agreed to sell all rights and assets to four generic pharmaceuticals to settle US Federal Trade Commission charges that its proposed $8.5 billion acquisition of Warner Chilcott would be anticompetitive. 28 September 2013
The USA’s Federal Trade Commission will require Mylan and Agila Specialties to divest 11 generic injectable drugs as a condition of allowing Mylan’s proposed $1.85 billion acquisition of Agila from parent Indian drugmaker Strides Arcolab. 27 September 2013
Australia’s Generic Medicines Industry Association this morning released the draft third edition of the GMiA Code of Practice, which incorporates a number of new amendments. 26 September 2013
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.