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Eli Lilly suffered a crushing defeat in the U.K. over patents for its lung cancer blockbuster Alimta (pemetrexed) as the U.K. High Court ruled in favor of Actavis' plan to market copycat versions of the med...The High Court's decision also applies to Actavis' generics in France, Italy and Spain...The company has a separate compound patent for the drug that expires in 2017. But certain patents for Alimta expire in 2021, and the latest ruling could throw a wrench in Lilly's plans to hold on to sales...Lilly is not pleased with the High Court's decision. "We strongly disagree with the ruling by the U.K. High Court" and "we plan to seek permission to appeal this ruling,"…The company has fared better with Alimta in the U.S., though. In August, a federal court ruled in favor of Lilly and granted the company 5 more years of U.S. exclusivity for the med. The court found that generic meds proposed by Teva Pharmaceutical Industries would infringe on Lilly's method patent for Alimta in combination with vitamins, allowing Lilly to hold on to the patent until 2022...

The Department of Justice is investigating potential fraudulent claims and billing linked to specialty creams...that claimed to treat pain symptoms...investigators have claimed many of these specialty creams have little or no medicinal value...the issue is with the alleged false claims, not the compounds themselves...It's part of a larger issue of healthcare fraud...All these people submitting claims … for drugs that have absolutely no effectiveness. Are they doing it with knowledge, and seeking reimbursement for it? It's the modern day snake oil salesman...the International Academy of Compounding Pharmacies said the creams in question "benefit people and are non-addictive."...No charges have been filed...

The government of Japan is changing the lucrative brand-name pharmaceutical market as its population ages and requires more drugs with a push to make at least 80% of the government's drug spending on generics by 2020...International brands are losing out to generic makers under the policies of Prime Minister Shinzo Abe who is pushing his ministers to make price cuts for branded drugs and speed up the shift to generics...Japan, like China and other countries with ageing populations, sees generics as the main way to rein in ballooning healthcare costs and the shift is not only affecting international players, but also domestic companies like Tokyo-based Takeda and would offload much of its off-patent and generic products...

A medical advisory panel to the Food and Drug Administration...recommended approval of a cheaper biosimilar form of Johnson & Johnson's Remicade (infliximab) arthritis drug that could eventually batter sales of the branded product...The panel, by a vote of 21-3, supported use of the biosimilar from Celltrion Inc and Pfizer Inc, called Remsima. The FDA usually, but not always, follows the advice of its advisory panels...The independent panel determined that clinical trials of Remsima showed no clinically significant differences with Remicade in treatment of rheumatoid arthritis and a related condition called ankylosing spondylitis...Moreover, the panel agreed Remsima is likely as safe and effective for other conditions Remicade treats, including psoriasis and inflammatory bowel conditions like Crohn's disease and ulcerative colitis, even though Remsima was not tested against those conditions.

In the latest government effort to penalize unfair competition among drug makers, the United Kingdom fined GlaxoSmithKline $54.5 million for illegally colluding with generic rivals to delay marketing lower-cost versions of the Paxil antidepressant...the UK Competitions and Market Authority found that between 2001 and 2004, Glaxo made payments totaling about $72 million to several generic companies. The deals were reached as part of a settlement to end patent litigation that was filed by Glaxo against the generic drug makers...Such settlements are known as pay-to-delay, since a brand-name drug company pays cash or transfers something else of value to a generic rival, which agrees to delay launching a copycat medicine. In 2001, Paxil was a blockbuster with sales in the UK exceeding $130 million...In this instance, the agreement deferred competition and potentially deprived the UK’s National Health Service of a lower-cost generic Paxil. UK authorities noted that when a generic version of Paxil eventually became available at the end of 2003, average prices fell by more than 70 percent in two years...Cracking down on these practices is essential to protect consumers, to encourage legitimate business activity that such practices stifle, and to stimulate innovation and growth...

As the only pharmacist serving in Congress, US Representative Earl L. "Buddy" Carter is a critical leader of efforts to pass federal legislation pertinent to pharmacists...Pharmacy Times recently spoke with the first-term US Congressman, House Community Pharmacy Caucus co-chair, and Carter’s Pharmacy, Inc, owner about his pharmacy past and political progress.

• Why did you become a pharmacist?
• What part of the pharmacy profession stands out to you?
• How did you get into politics?
• Have you maintained your pharmacist license while serving in Congress?
• What is it like to be a pharmacist in Congress?
• How has being a pharmacist helped you understand and tackle legislative issues?
• What pharmacy-related objectives are on your to-do list in Congress?
• What are your thoughts about pharmacist provider status legislation and how are you advancing HR 592?
• What are your thoughts about PBM transparency legislation and how are you advancing HR 244?
• What are your thoughts about "any willing pharmacy" legislation and how are you advancing HR 793?
• What more do you plan to do to advance these 3 bills?
• What efforts is the House Community Pharmacy Caucus making to help community pharmacists?

With no signs of a resolution anytime soon, junior doctors in England have once again taken to picket lines across the country in protest against working and pay conditions being proposed by the government...Around 2,800 operations have reportedly been cancelled as doctors stage a 24-hour walk-out providing only emergency care, after several years of discussions with the government about a new contract have failed to find common ground...The British Medical Association is most concerned with the government’s refusal to recognise Saturday working as unsocial hours, which would see junior doctors take a drop in salary despite an 11 percent rise in basic pay, the removal of safeguards to ensure that doctors aren’t over-worked, as well as the threat to impose the proposed contract if a resolution isn’t reached...imposing the contract would not be a popular move. Almost 90 percent of junior doctors said they would consider resigning from the NHS if the government does so...

Theranos Inc. filed a plan to U.S. regulators to fix serious deficiencies at the company’s blood-testing lab in Newark, California, as founder Elizabeth Holmes works to regain credibility for her struggling startup...The company submitted the proposed plan of correction...to the Centers for Medicare and Medicaid Services...Theranos also confirmed the filing, though it didn’t release details of the plan...CMS said in late January that Theranos’s violations of federal regulations posed "immediate jeopardy" to patients’ health and safety...Walgreens Boots Alliance Inc. and...Capital BlueCross have said they’re curtailing use of Theranos’s tests while the shortcomings identified by CMS are addressed. Theranos has hired a new lab director and said it’s working quickly to correct other problems, including personnel issues, along with the defects tied to blood testing...

Mike Glaicar, Business Development: Pharmacy Times...(PTNN) This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Declines in the value of the Egyptian pound coupled with a shortage of foreign exchange have made it harder for Egyptian pharmaceutical companies to import active ingredients they need to make generic medicines millions of poor Egyptians rely on...Though medicines are classed as essential goods, putting them high on the priority list at banks deciding how to allocate precious dollar rations, pharmaceutical companies say they still face serious problems that force them to slow or pause production...A weaker currency has also made it more expensive to import raw materials while the price of finished medicines is fixed by the Health Ministry, forcing manufacturers to stop making some cheap generic medicines to staunch growing financial losses...