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Generics
In a recent interview with Times of India, a trade association that represents several major generic drug manufacturers in India has attempted to justify the issuance of compulsory licenses by alleging that the USA has done the same by allowing temporary importation of certain drugs. 27 August 2012
Pharmaceutical
At a press conference in Athens last week, the President of the Greek research-based pharma association SFEE, Konstantinos Frouzis, called for immediate actions by the government to support patients, stating that SFEE can act as an institutional consultant of the government. In this way, the effectiveness of government interventions can be maximized, without jeopardizing citizens' access to medicines. 12 July 2012
Biotechnology
Government initiatives to cut health expenditure are likely to encourage sales of generic medications in Europe, according to a new report by health care experts GBI Research, which predicts an increase in revenue made by generics in the region during the next five years, as cost-containment policies strongly support the consumption of generic drugs over innovative drug use. 9 July 2012
Pharmaceutical
The controversial Anti-Counterfeiting Trade Agreement (ACTA) was rejected by the European Parliament on Wednesday, and hence cannot become law in the European Union. This was the first time that Parliament exercised its Lisbon Treaty power to reject an international trade agreement. A total of 478 Members of the European Parliament (MEPs) voted against the ACTA, 39 were in favor, with 165 abstaining. 5 July 2012
Generics
Russia should open its booming $19 billion pharmaceuticals market and expedite the list of 500 drugs that it currently imports from India, said India's Commerce, Industry and Textiles Minister Anand Sharma during a recent visit to St Petersburg, urging Russian authorities to let Indian pharmaceutical companies form joint partnerships with Russian companies, reports the Indian Business Standard newspaper. 4 July 2012
Pharmaceutical
In a five to four decision delivered yesterday by Chief Justice John Roberts, the US Supreme Court upheld most of President Barack Obama's signature health care reform act, or the Affordable Care Act dubbed "Obamacare," which has been strongly opposed by Republicans, who have said they would repeal the bill if they gained power. 29 June 2012
Pharmaceutical
Europe's pharmaceutical industry is facing two huge problems: drug reference pricing and parallel trade (the re-exportation of pharmaceutical products from lower-priced to higher-priced countries), which represent a threat to orderly supply of medicines in the region, warned Sir Andrew Witty, president of the European Federation of Pharmaceutical Manufacturers and Associations (EFPIA) in a letter sent to European Union leaders, Commission President Jose Manuel Barroso and Council President Herman Van Rompuy ahead of the June 28-29 summit. 26 June 2012
Pharmaceutical
For the first time, nine Members of the European Parliament (MEPs) 65 leading trade unions, civil society organizations, health organizations and industry associations have united in an open letter calling on European leaders to stop cutting essential health and welfare systems and focus on ordinary people living in Europe coping with the dire impact of a financial crisis of which they are the first victims. 25 June 2012
Biotechnology
The US Congress has released a reconciled Prescription Drug User Fee Act (PDUFA) reauthorization bill that is effectively a comprise on two sets of legislation that were passed by the Senate (the Food and Drug Administration Safety and Innovation Act; FDASIA) and House of Representatives (PPDUFA), respectively, last month (The Pharma Letters May 28 and June 1). 20 June 2012
Biotechnology
Standardized research guidelines are needed to control and encourage the development of gene therapy and stem cell treatments, according to a new report by health care experts GBI Research. The new report shows how regenerative medicine is seen as an area with high future potential, as countries need ways to cope with the burden of an aging population. 11 June 2012
Biotechnology
Leading pharmaceutical companies in Europe, represented in the European Federation of Pharmaceutical Industries and Associations (EFPIA), meeting in Berlin last Friday, called on the German government for urgent action to protect patient access to new medicines and ensure that Germany remains a home for pharmaceutical innovation. 11 June 2012
Pharmaceutical
Regardless of how the Supreme Court rules on the Affordable Care Act, US drug major Eli Lilly (NYSE: LLY) will continue to advocate for reforms that enhance patient access to good health care and medicines, provide consumer choice through market-based competition, promote prevention and evidence-based disease management, foster future medical innovation, and maintain high standards of quality and safety, said John Lechleiter, chairman, president and chief executive officer of the company. 7 June 2012
Biotechnology
The UK government is too focused on encouraging "breakthrough drugs" at the expense of significant gains for patients from incremental innovation in medicines, warned Stephen Whitehead, chief executive of the trade group Association of the British Pharmaceutical Industry (ABPI). He argued that this approach threatens the future of pharmaceutical medical research in the UK. 6 June 2012
Pharmaceutical
Now that the US House of Representatives and the Senate have passed HR 5651 and S 3187 (the FDA Safety and Innovation Act), respectively, focus will move to a conference committee, which will iron out differences between the bills and reach a compromise, comments Karl Karst on law firm Hyman, Phelps & McNamara's FDA Law Blog. 4 June 2012
Generics
Just days after the US Senate overwhelming approved the Food and Drug Administration Safety and Innovation Act (FDASIA), which included reauthorization of the Prescription Drug User Fee Act (PDUFA; The Pharma Letter May 28), the House of Representatives followed suit, passing the Food and Drug Administration Reform Act of 2012 (HR 5651) in a 387 to five vote. 1 June 2012
Biotechnology
A provision in the Food and Drug Administration Reform Act that would block public access to potentially important health and safety information should be removed or substantially narrowed, say consumer advocacy organization Public Citizen and 20 other groups in a letter sent to key lawmakers. 30 May 2012
Pharmaceutical
Responding to the recent debate in Ireland's Parliament (Dail), the Irish Pharmaceutical Healthcare Association (IPHA) has rejected comments made on the availability, cost and access to medicines in the country. 28 May 2012
Biotechnology
The US Senate approved the Food and Drug Administration Safety and Innovation Act (FDASIA), which includes a reauthorization of the Prescription Drug User Fee Act (PDUFA), last Thursday, in a move welcomed by both the Biotechnology Industry Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA). 28 May 2012
Biotechnology
Public Citizen strongly supports a measure proposed by US Senator Bernie Sanders (Independent, Vermont) that would more effectively curb fraudulent activity committed by the pharmaceutical industry against the federal and state governments, stated Sammy Almashat, a researcher at the US consumer advocacy group. 23 May 2012
Pharmaceutical
The US House of Representatives has budgeted $193 million more to global AIDS programs in the 2013 Foreign Operations & Appropriations Bill than President Barack Obama proposed. Despite a 5%, or $2 billion, reduction in overall foreign operations spending from the fiscal year 2012 Appropriations Bill, the House budget would maintain current levels of funding. This is in stark contrast to the Administration's unprecedented request for a reduction in global AIDS funding, commented the USA-based AIDS Healthcare Foundation (AHF), which lauded the move. 22 May 2012
Pharmaceutical
The nomination of Robert F Kennedy Jr — known as RFK Jr — for the role of US Secretary of the Department of Health and Human Services (HHS) President-elect Donald Trump sent shares in vaccine companies sharply downwards. 22 November 2024
article
The UK government has reappointed BioIndustry Association (BIA) chairman Daniel Mahony as its Life Sciences Investment Envoy. 21 November 2024
Pharmaceutical
The Danish government’s newly-unveiled health reform has been praised for tackling chronic disease care and health inequalities while driving health innovation. 18 November 2024
Pharmaceutical
New research published by the European Federation of Pharmaceutical Industries and Associations (EFPIA) provides in-depth analysis of the economic footprint of the pharmaceutical industry in Europe, across member states and compares Europe to other regions of the world. 18 November 2024
Pharmaceutical
Johnson & Johnson has taken legal action to defend a contentious rebate initiative, filing a lawsuit in the US District Court for the District of Columbia. 15 November 2024
Pharmaceutical
The share prices of Pfizer, GSK, Novavax and other vaccine companies were all markedly lower on Friday. This was not due to the publication of disappointing research results in the sphere, or an ominous stance taken by a major regulator on a key filing, but rather a political development that could spell trouble for the vaccines field as a whole. 15 November 2024
Biotechnology
BeiGene has announced plans to rebrand as BeOne Medicines, a move the cancer specialist says reflects its commitment to fighting cancer through collaboration. 15 November 2024
Pharmaceutical
Danish patients are being offered fewer innovative treatments than Norwegians and Swedes, a new estimate from the Danish Medicines Council shows. 11 November 2024
Pharmaceutical
According to the Swedish pharma trade group Lif, it is positive that, in the updated life science strategy, the government expresses an ambition for Sweden to become more attractive for research investments. 11 November 2024
Pharmaceutical
Li Li, Commissioner of China's National Medical Products Administration (NMPA), and Mette Aaboe Hansen, interim director general of Danish Medicines Agency, have signed a letter of intent to promote bilateral cooperation in regulation of drugs and medical devices. 11 November 2024
Pharmaceutical
Following the news that Donald Trump is the winner of the 2024 US Presidential Election, Morningstar Equity analyst Julie Utterback has published a new note about the impact of this on the managed-care industry. 7 November 2024
Pharmaceutical
UK pharma major AstraZeneca, which has invested heavily in China, hosted a sell-side analyst call on Wednesday (November 6) to discuss the recent media reports about ongoing investigations in China. 7 November 2024
Pharmaceutical
Some of the UK’s leading academics and industry professionals have welcomed Chancellor Rachel Reeves’ £520 million ($669 million) pledge to develop the country’s medicine manufacturing capabilities. 6 November 2024
Pharmaceutical
European regulators will decide by December 6 whether Novo Holdings, the controlling shareholder of Danish pharma giant Novo Nordisk, can finalize its $16.5 billion acquisition of contract drug manufacturer Catalent. 5 November 2024
Pharmaceutical
The Danish government is rolling out the red carpet and welcomes several pharmaceutical companies. 4 November 2024
Generics
Medicines for Europe has launched a study of market barriers faced by European generics and biosimilar pharmaceutical companies operating in 11 key third-country markets. 31 October 2024
Pharmaceutical
Following the first Labour budget for 14 years, the Association of the British Pharmaceutical Industry (ABPI) welcomes Chancellor Rachel Reeves’ measures to improve UK life sciences competitiveness. 30 October 2024
Pharmaceutical
HOPO Therapeutics has been awarded a contract valued at up to $226 million from the Biomedical Advanced Research and Development Authority (BARDA). 29 October 2024
Pharmaceutical
The Danish government has presented part of the plan for a future life science strategy, which has been welcomed by the industry. 28 October 2024
Biotechnology
Legend Biotech has removed Genscript Biotech as its majority shareholder, in a move coinciding with rising US concerns over Chinese ties within the biotech sector. 24 October 2024
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