Pharma News
Valeant deal to acquire Actavis on hold
Drugmaker Valeant Pharmaceuticals International (Valeant) was in talks to acquire generics manufacturer Actavis for more than US$13 billion, in what would rank as one of the biggest healthcare deals this year. However, reports are that the deal is now on hold.
UK accuses GSK of delaying generics
The UK’s competition watchdog is accusing GlaxoSmithKline (GSK) of delaying the entry of generics to its antidepressant drug Seroxat (paroxetine) by paying rival companies to stay off the market.
Generics drugmakers should be held responsible for injuries
In the long saga of generics pre-emption, The New York Times is adding its opinion to the argument of whether generics makers are liable for injuries caused by their products. The newspaper believes that ‘manufacturers should bear responsibility for making sure their drugs are safe and effective’ and is urging US Congress to amend laws to allow patients to sue generics manufacturers.
Greece and Syria facing severe drug shortages
Greece and Syria are both facing severe shortages in essential medicines, but for very different reasons.
Drugmakers accused of stopping shipments to Greece
Greece is facing a severe drug shortage in more than 200 drugs. The worrying situation is being blamed on drugmakers that have stopped shipping their products to the country due to debts or fear of parallel trade.
Drug shortages linked to quality control costs
Lack of reward for manufacturing quality is forcing manufacturers of sterile injectable generics to reduce investments into quality system and is leading to drug shortages, according to FDA officials [1].
Sun Pharma ends attempt to gain full control of Taro
Sun Pharmaceutical Industries (Sun Pharma) announced on 8 February 2013 that it had given up on its effort to buy the remaining stock of Taro Pharmaceutical Industries (Taro) for about US$685 million after Taro shareholders held out for a higher price.
EC accuses J&J and Novartis of delaying generic fentanyl
On 31 January 2013 the European Commission (EC) sent a statement of objections, to US-based Johnson & Johnson (J&J) and Switzerland-based Novartis accusing them of delayed entry of a generic painkiller.
Generic Doxil approval may help alleviate drug shortages
FDA announced on 4 February 2013 that the agency had approved the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection).
Top 10 most read GaBI Online articles in 2012
2012 was a busy year with lots of developments in biosimilars from regulatory guidelines to comparability issues. Biosimilars remain as the hot topic of the year for GaBI Online.
Brand-name drugmaker can be sued for harm caused by generic drug
On 4 January 2013 the Alabama Supreme Court ruled that Pfizer can be sued for failing to warn about a drug’s risks by a patient who claimed he was injured by a generic version of its gastric reflux medicine Reglan (metoclopramide).
Teva makes South Korean joint venture agreement
Teva Pharmaceutical Industries (Teva) announced on 16 December 2012 that it had made an agreement with Handok Pharmaceuticals (Handok) to establish a business venture in South Korea.
Teva cost-cutting and re-organization
Teva Pharmaceutical Industries’ (Teva’s) new Chief Executive vowed to reshape the drugmaker and reduce annual costs by up to US$2 billion over the next five years, making it into ‘the most indispensable medicines company in the world’.
Eli Lilly and Strides Arcolab in generics deal
Pharma giant Eli Lilly and India-based generics manufacturer Strides Arcolab announced on 5 December 2012 a collaboration to market the latter’s generic cancer drugs in emerging markets.
Sanofi to acquire Colombian generics maker
Healthcare major Sanofi announced on 2 October 2012 that it has signed an agreement to acquire Colombian generics manufacturer Laboratorios Genfar (Genfar), making Sanofi a market leader in Colombia and expand its portfolio of affordable pharmaceuticals in Latin America.
GPhA drug shortages plan gets FTC approval
On 8 August 2012 the US Federal Trade Commission (FTC) issued a positive advisory opinion to the Generic Pharmaceutical Association (GPhA) approving its Accelerated Recovery Initiative (ARI), which hopes to address drug shortage issues, after the FTC found the ARI will not be anticompetitive as sensitive information will be protected.
Fresenius cashes in on drug shortages
German healthcare conglomerate Fresenius has posted substantial growth across all regions and product areas during the first half of 2012 for its US business Fresenius Kabi. The growth has been largely attributed to rivals’ problems with supplying generics on the drug shortages list in the US.
Generics market set to increase in Japan
Japan has not been an easy place for drugmakers to do business. However, with government initiatives being introduced to increase generics use and taking into account the fact that Japan is currently the world’s second largest pharmaceutical market, it is perhaps not surprising that a new partnership is optimistic about the opportunities.
Sun Pharma finally gains full control of Taro
Sun Pharmaceutical Industries (Sun Pharma) and Taro Pharmaceutical Industries (Taro) announced on 13 August 2012 that they have entered into a merger agreement together. India-based Sun Pharma has agreed to pay out an additional US$600 million in order to finally gain full control of Israel-based Taro.
Fuji Pharma acquires OLIC Thailand
Fuji Pharma Co Ltd announced on 3 August 2012 that it has entered into an agreement to acquire the shares of OLIC (Thailand) Ltd, the largest pharmaceutical contract manufacturer in Thailand.
Generics makers Sun and Stada considering deal
Rumours are that Indian-based generics manufacturer Sun Pharma and Germany’s generics maker Stada Arzneimittel (Stada) may be looking at a deal in the near future, although both sides deny or refuse to comment on the matter.
Political battle over US health care continues
It was not the end of the story when the Affordable Care Act was passed in 2010. Its implementation is being fought every inch of the way; the Republican Party is split even though voter polls say 70% would scrap the whole Act or at least its central plank.
Drug shortages are persisting
The media are reporting continuing problems on drug shortages, and indeed a worsening situation around the world. Cancer drugs seem to be the most affected.
APPG reports on drug shortages and MHRA bans unlicensed stock trading
On 14 May 2012, the All-Party Pharmacy Group (APPG) published the results of its inquiry into drug shortages in the UK. In response to this the Medicines and Healthcare products Regulatory Agency (MHRA) has decided to ban unlicensed stock trading by pharmacists.
IMS Health enlisted as information provider for drug shortages
The Generic Pharmaceutical Association (GPhA) announced on 19 April 2012 that it had selected IMS Health (IMS) to serve as the Independent Third Party in the Accelerated Recovery Initiative (ARI), providing information on generic drug shortages to FDA.
Also noted on pharma: 11 May 2012
UK government considers carrying out survey on drug shortages
The UK Department of Health (DoH) is considering a one-off survey of community pharmacies in England to assess the impact of drug shortages, Health Minister Simon Burns has confirmed. The move has followed requests from Ministers of Parliament (MPs) to carry out such a survey.
MP Irranca-Davies said, ‘in the meantime, I urge pharmacists and GPs to write to their MPs and demand that they lobby the health minister to carry out this research.’
The problem is far from being resolved, a Chemist+Druggist’s 2011 Stock Survey of pharmacies in the UK found that more than 140 pharmacists had seen a patient’s health suffer because of supply problems.
Related articles
UK drug shortages are far from being solved
UK drug shortages continue to affect pharmacists and patients
Members of parliament to hold inquiry into UK drug shortages
Source: Chemist+Druggist
FDA says efforts to prevent drug shortages are working
FDA Commissioner Ms Margaret Hamburg has reported that the FDA’s office of drug shortages has made progress in preventing drug shortages and working with industry to provide advanced warning when the agency is unable to prevent a shortage. In a posting on the agency’s FDA Voice Blog on 3 May 2012, Ms Hamburg said that she was ‘both amazed and delighted to see the progress that’s been made’.
Amgen enters biosimilars deal with PRA
Clinical Research Organisation (CRO) PRA announced on 26 April 2012 that it had entered into an agreement with US biotechnology giant Amgen as the sole provider of CRO services for ‘a series of phase III studies to develop several biosimilar drugs on a worldwide basis’.
CMS rules add to US drug shortages
Results of a survey carried out by the Institute for Safe Medication Practices (ISMP) and published on 22 March 2012 point to the fact that ‘too strict’ rules from the US Centers for Medicare & Medicaid Services (CMS) have led to waste of medications already in short supply.
Also noted on pharma: 13 April 2012
Drug shortages increase again in 2011
Despite efforts by FDA the number of drugs in short supply has increased again in 2011, according to data from the University of Utah, USA. Levels are more than 4.5 times higher than in 2004, when 58 drugs were reported to be in short supply, and have reached a new record high of 267 drugs experiencing shortages.
Related article
Record high drug shortages in the US
Source: The Washington Post
Also noted on pharma: 6 April 2012
MPs concerned over medicines shortages in UK
Nineteen UK Ministers of Parliament (MP) have now signed a Parliamentary motion demanding that the government holds ‘urgent discussions’ on the selling of UK medicines abroad, which according to many is only serving to exacerbate the current drug shortage situation in the UK.
Source: Chemist & Druggist
Canada drug shortages
Sandoz, the generics unit of pharma giant Novartis, is at the centre of Canadian drug shortages, however, the company is assuring Canadians that it will not raise prices of drugs sourced from overseas.
Top 10 most read GaBI Online articles in 2011
2011 was a busy year and biosimilars was the hot topic of the year for GaBI Online.
GaBI launches GaBI Journal
- A new information source for generics and biosimilars -
Canada’s generics and brand-name pharma come together to tackle drug shortages
Canada’s Research-Based Pharmaceutical Companies (Rx&D) and the Canadian Generic Pharmaceutical Association (CGPA) announced on 12 March 2012 their commitment and financial support in responding urgently to prescription drug shortages.
Greece drug shortages
A severe drug shortage is threatening to undermine the health and welfare of Greek citizens as prescription drugs and even basic over-the-counter medicines are in increasingly short supply. Even finding common drugs such as Aspirin has become a major problem in Greece.
Score lines won’t delay generics
In an attempt to delay generics competition, Irish pharma company Warner Chilcott had added a second line or score to its Doryx (doxycycline hyclate) tablet. On 8 February 2012, FDA however denied the company’s citizen petition demanding that generic versions should also have the two score lines.
UK drug shortages are far from being solved
Despite attempts to solve problems with shortages of brand-name medicines in the UK, the issue is taking up more of pharmacists’ time, is far from being solved and may be getting worse according to an online stock survey carried out by pharmacists organisation Chemist+Druggist.
Drug shortage woes continue in the UK
Despite attempts to solve problems with shortages of brand-name medicines in the UK, the issue is far from beings resolved. The latest news is that the UK’s wholesalers have called for a ‘third-party monitoring and survey service’ to help tackle medicines shortages, while the Association of the British Pharmaceutical Industry (ABPI) is calling for sanctions on pharmacists that act as wholesalers.
Shortages of ADHD drugs expected during 2012
Drugs used to treat attention deficit hyperactivity disorder (ADHD) are in such short supply that FDA has reported that it receives hundreds of complaints from patients unable to fill their prescriptions.
