Pharma News
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.
UK drug shortages continue to affect pharmacists and patients
Shortages of brand-name medicines are as much of a problem in 2011 as they were in 2010, according to a survey by the Pharmaceutical Services Negotiating Committee (PSNC).
Hospira’s manufacturing troubles may add to drug shortages
Injectable generics specialist, Hospira, is under scrutiny again regarding drug shortages caused by its continuing lack of compliance with FDA requirements. In fact, one analyst from The Wall Street believes that the company has production problems that require long-term attention and that could lead to it receiving a consent decree from FDA.
Biosimilars and cancer drug shortages in Europe
With all the talk about drug shortages in the US it might be easy to forget the rest of the world, but it seems that drug shortages are also hitting European countries and are affecting not just generics, but also biosimilars.
Members of parliament to hold inquiry into UK drug shortages
On 21 November 2011, a group of UK members of parliament (MPs) announced that they will hold a full-scale inquiry into the continuing problem of drug shortages within the National Health Service (NHS).
Some relief from drug shortages in the US
There finally appears to be some light at the end of the tunnel, with one of the main victims of shortages—the sterile injectable drug propofol—finally being declared no longer in short supply by FDA.
Obama’s fresh attempts to ease drugs shortages in the US
Action by the President
President Barack Obama signed an executive order 31 October 2011 to address an escalating shortage of life-saving medicines, his newest effort to advance social and economic measures that have stalled in Congress.
Cancer drug shortages in the US
There is concern being expressed about the growing number of drug shortages among essential and lifesaving cancer drugs.
Sun Pharma offers to buy remaining Taro shares
Taro Pharmaceutical Industries confirmed that it had received a letter on 19 October 2011 from Sun Pharma offering to buy all outstanding shares of Taro, not currently held by Sun Pharma, at a price of US$24.50 per share.
Pfizer invests Euros 145 million in Irish biotech site
Pfizer, the world’s leading pharmaceutical company, is to make a substantial investment of Euros 145 million at its Grange Castle biotechnology manufacturing facility in Clondalkin, Dublin, Ireland, it was revealed 22 September 2011.
Drawing score lines on pills to delay generics
Brand-name drugmakers have come up with numerous ways in the past to delay generics from entering the market. These can include making slight changes to the doses, introducing a paediatric form, pay-for-delay deals or even buying the company that makes the active pharmaceutical ingredient. The latest novel tactic from an originator drug company, however, is coming simply in the form of a line.
Aurobindo forms generics joint venture with Russia’s Diod
India-based Aurobindo Pharma (Aurobindo) announced on 7 September 2011 that it had formed a joint venture with Russian company Ojsc Diod (Diod) to manufacture and sell pharmaceutical products in Belarus, Kazakhstan and Russia.
Pfizer and US pharmacies fight counterfeit medicines
Pfizer and the US National Association of Boards of Pharmacy (NABP) announced on 29 September 2011 that they have launched a new effort to draw attention to the risks associated with counterfeit drugs and to help patients learn how to buy medicines online safely.
Sun Pharma’s US operations partially on track
Sun Pharma announced on 19 September 2011 that its US arm has resolved issues raised by the country’s health regulator regarding violation of manufacturing standards.
Authorised generics implicated in pay-to-delay deals
A US Federal Trade Commission (FTC) report has found that authorised generics may reduce generics competition. The report also shows that some originator companies may have used agreements not to launch an authorised generic drug as a way to compensate would-be generic competitors for delaying entry into the market.
Eli Lilly in deal with Turkish generics company
American drugmaker Eli Lilly is in talks to form a partnership with, and potentially invest in, Turkish generic drugs company Mustafa Nevzat İlaç Sanayii A.Ş. (MN Pharmaceuticals), according to a Wall Street Journal report from 2 September 2011.
Medivir subsidiary BioPhausia sells generics business
Sweden-based Medivir announced on 25 August 2011 that its subsidiary BioPhausia had reached an agreement to sell its generics business (BMM Pharma) to Bluefish Pharmaceuticals (Bluefish) for SEK 26 million plus the value of inventories, some SEK 12 million. The staff of BMM Pharma will not be transferred in the acquisition.
GaBI Online launches its country focus section
- Provides Easy to Find Country Specific Information -
FIRST IN THE SPOTLIGHT – BELGIUM, THE NETHERLANDS AND UK
Generics of antibiotic Levaquin approved by FDA
The FDA has approved the first generic versions of Johnson and Johnson’s (J&J) blockbuster antibiotic Levaquin (levofloxacin), used to treat bacterial infections of the skin, sinuses, kidneys, bladder, and prostate caused by specific germs.
Record high drug shortages in the US
In 2010, there were 178 drugs that experienced shortages in the US, see Figure 1. This is a record high level and regulators blame quality and manufacturing problems for the crisis. Worse still, many of the drugs identified in 2010 remain unavailable or in short supply in 2011.
Watson buys Greek generic maker Specifar
Watson Pharmaceuticals announced on 25 May 2011 that it had bought the Greece-based generic manufacturer Specifar Pharmaceuticals for Euros 400 million with the intention of increasing its generics presence in Europe.
Pay-to-delay deals up by 60% in US
The number of deals struck between brand-name and generic pharmaceutical companies in the US are on the rise, despite efforts by the US Federal Trade Commission (FTC) to restrict agreements that delay the introduction of lower-cost medicines, according to a report from the agency.
Generics and biosimilars to drive down drug spending
A report published by IMS Health on 18 May 2011 predicts a slowing down of the growth in annual spending on medicines, with generics being one of the main contributing factors for this reduction.
Teva expands in Japan – buying generic’s maker Taiyo
Teva is on the prowl again—grabbing yet another smaller generics manufacturer—and increasing its presence in the lucrative Japanese market. The Israeli generics giant announced on 16 May 2011 that it had agreed to buy a 57% stake in Japan-based Taiyo Pharmaceutical Industry for US$460 million.
Teva finally gets troubled Irvine plant back in action
Teva told the Wall Street Journal, on 3 May 2011 that its injectables facility in the US, which was shut down a year ago after quality control problems, has now received the green light from the FDA and has restarted production.
Teva – a moving target
Teva Pharmaceutical Industries has grown rapidly since the forerunner of today’s firm was born in 1976. It has achieved its vision of becoming the world’s number one generics manufacturer, or as it puts it ‘its commitment to providing consumers with access to high-quality, affordable medicines’. It takes a great many legal wrangles and much forward planning to maintain this position.
China to power global generics development
Analysts estimate that China will overtake France and Germany as the world’s third-largest prescription medicines market in 2012, trailing only the US and Japan.
The latest on healthcare austerity in Greece
Greece is seeking to save approximately Euros 900 million a year and reduce the share of gross domestic product accounted for by healthcare spending from more than 10% in 2008 to under 6%. To help to achieve this, the maximum price of generic drugs will be set at no more than 60% of the originator product’s price, rather than 72% as originally proposed in September 2010.
Hikma buying into the US market
Hikma is buying some of Baxter’s injectable products that are sold primarily in the US, including chronic pain, anti-infective and anti-emetic products, along with the Cherry Hill manufacturing facility and the Memphis warehouse and distribution centre. Approximately 750 employees will also transfer as part of the arrangement.
Caraco and Sun to merge
Caraco Pharmaceutical Laboratories announced on 22 February 2011 that it had entered into a merger agreement with generics manufacturer Sun Pharmaceutical Industries and its wholly-owned subsidiary Sun Pharma Global.
FDA rejects second citizen petition for Teva’s glatiramer acetate drug
Teva Pharmaceutical Industries’ glatiramer acetate drug (Copaxone) is indicated for reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis.
Mylan in and out of hot water
On 26 January 2011 Mylan, the second-largest US generics manufacturer, announced a truce with global pharma giant Pfizer, which will enable the former to sell generic versions of the cholesterol drug Lipitor (atorvastatin) and combination blood pressure and cholesterol treatment Caduet (amlodipine/atorvastatin).
Valeant acquires generics’ manufacturer PharmaSwiss
Valeant Pharmaceuticals International and PharmaSwiss announced on 1 February 2011 that they had signed a binding agreement for Valeant to acquire generics’ manufacturer PharmaSwiss for Euros 350 million. Valeant expects the deal to strengthen its presence in Central and Eastern Europe.
Rights to Allegra acquired by generics’ manufacturer Perrigo
On 29 June 2010, Perrigo announced that it had acquired the exclusive US rights to sell and distribute OTC versions of Fexofenadine HCl 180 mg and 60 mg tablets, plus Fexofenadine HCl 60 mg and Pseudoephedrine 120 mg tablets, the generic versions of sanofi-aventis’ Allegra and Allegra D-12 products. Teva Pharmaceutical Industries currently has prescription (Rx) approval for these products, and Teva and sanofi-aventis have settled their Paragraph IV litigation.
Perrigo buys Paddock for US$540 million
Perrigo Company may not be a household name, but nevertheless life is exciting for a medium-sized company in the pharmaceuticals world. Undeterred by a pending FDA warning letter about its Michigan facility, Perrigo recently entered into a definitive agreement to take over Paddock Laboratories in a cash deal worth Euros 394 million.
Teva increases stake in Mediwound to 51%
Israel’s Teva Pharmaceutical Industries is increasing its stake in biotechnology company MediWound Ltd to 51% under a multi-tiered deal to develop and commercialise products to treat burns and wounds.
Ranbaxy’s profits soar, but US ban still looms
The generics’ giant and India’s largest pharmaceutical manufacturer, Ranbaxy, has reported strong results for the third quarter of 2010, but concerns remain about the US import ban that is still in place on many of the firm’s generics.
Cost of new drug challenged
An editorial in the New England Journal of Medicine (NEJM) issue of 23 September 2010 took the unusual position of challenging a study published in the same issue.
Pfizer buys 40% stake in Brazilian generics’ manufacturer Teuto
Pfizer, the world's biggest pharma company, is increasing its stake in emerging markets, with its announcement on 20 October 2010 that it has entered into an agreement to acquire a 40% stake in Brazilian generics’ manufacturer Laboratorio Teuto Brasileiro (Teuto) for US$240 million.
China’s booming pharmaceutical market attracts R & D
China, which is approximately the size of the US, but with five times the population, has long been off-limits for global pharma due to its complex regulations, low healthcare expenditure and its seemingly unenforceable intellectual property laws. However all that has apparently changed according to a Reuters analysis, which shows that China is grabbing an increasing share of the global R & D budget, with investigators launching new studies to help understand how to treat the country’s huge population and tap into one of the fastest growing pharma markets on the planet.
