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U.S. HOUSE VOTES AGAIN TO REPEAL HEALTH LAW -- The Republican-controlled U.S. House of Representatives voted to repeal President Barack Obama’s healthcare reform law on Thursday in a symbolic move aimed as much at healing internal Republican rifts as demonstrating dogged party opposition to “Obamacare.” The 229-195 vote occurred largely along party lines and marked the 37th time the House has voted to repeal or defund the 2010 Patient Protection and Affordable Care Act, which is now in the final months before full implementation on January 1. Like previous attempts to dismantle the law, the measure will likely go nowhere in the Democratic-run Senate. For Republicans, who hope to make Obamacare a winning campaign issue in the 2014 congressional midterm elections, the action gave House freshmen their first chance to vote against a law that is unpopular with a large number of voters, particularly conservatives in their districts back home. “A full repeal is needed to keep this law from doing more damage to our economy and raising healthcare costs,” said House Speaker John Boehner at a press conference alongside a seven-foot, three-inch tall stack of paper labeled “Obama Regulations @theredtapetower.”

      Democrats poked fun at the latest repeal vote. “Apparently, the Republicans are opposed to Obamacare,” said Representative Steny Hoyer, the second-ranking House Democrat. “I know that comes as a shock to America, so we need to tell them one more time. Or 37 times, or maybe a 38th, or a 100th time.” The repeal measure was authored by Representative Michele Bachmann, former Republican presidential candidate and Tea Party leader, who sought to link healthcare reform to an Internal Revenue Service scandal that is threatening to undermine Obama’s second-term agenda. “No matter what, Americans will not want a politicized agency to have access to their most personal, intimate healthcare information or be in charge of important healthcare decisions,” Bachmann said.

      The reform law, Obama’s signature domestic policy achievement, will bring sweeping change to the $2.8 U.S. trillion healthcare system and provide health coverage to 37 million people through subsidized private plans and an expansion of the Medicaid program for the poor.

DRUG COMPANIES PURSUE ACTAVIS DEAL -- A heated takeover battle has erupted around generic-drug company Actavis Inc. (Parsippany NJ) as industry players seek to shore themselves up amid increasing competition and fewer new generic-drug opportunities. Valeant Pharmaceuticals International Inc. (Laval, Quebec) and Mylan Inc. (Canonsburg PA) are evaluating their options after approaches they made for Actavis were rebuffed, according to people familiar with the matter. Meanwhile, Novartis AG (Basel), the Swiss pharmaceuticals giant, was said to be considering whether to enter the fray, possibly by launching its own bid for Actavis. But a Novartis spokesman said Thursday the company had “no intention of pursuing them.” Actavis, which has a market capitalization of nearly $16 billion, is also in negotiations to buy smaller rival Warner Chilcott Plc (Dublin IRL), the companies disclosed last week. It is unclear whether any new takeover offer for Actavis will materialize or whether the company will ultimately seal a deal for Warner Chilcott, which has failed in prior efforts to sell itself. But the companies’ scramble to consolidate shows how the generic-drug industry’s dynamics have become more challenging amid intense price competition and fewer opportunities to cash in on patent expirations of big-selling branded pharmaceuticals.

      In January, Actavis predicted price erosion across its business this year by a mid-single-digit percentage in the U.S. and by a high-single-digit percentage outside the U.S. Analysts also say the industry is ripe for consolidation because it remains relatively fragmented and companies need critical mass to compete. At the center of the takeover race is Actavis, the world’s third-largest generic-drug company by sales. Among its products are the enlarged-prostate treatment Rapaflo and Gelnique for an overactive bladder. About 75% of Actavis’s sales still come from generic drugs, including versions of Pfizer Inc.’s (New York) cholesterol-lowering pill Lipitor, and Johnson & Johnson’s (New Brunswick NJ) Concerta treatment for attention-deficit and hyperactivity disorder. Actavis shares closed the week up $5.64, or 5%, at $125.50. The stock had risen more than 20% since Valeant’s pursuit of the company surfaced. Shares of Warner Chilcott, which focuses on gastroenterology, dermatology and urology, closed the week up 17% at 15.078 euros in Dublin.

TRACKING WASHINGTON -- Two million fewer people than previously estimated will gain health coverage under the U.S. Affordable Care Act as new rules allow some uninsured Americans to avoid a mandate for participation, the Congressional Budget Office said. About 25 million uninsured people are expected to gain coverage through use of subsidized health plans or an expansion of Medicaid, down from a 27 million estimate made in February, the budget office said in a report. Proposed regulations from the Treasury and Health and Human Services departments would let as many as one million more people escape penalties for going without insurance, the budget office said. The CBO’s estimate of the number of people who will gain coverage has slid from a high of 34 million in 2011, a year after the law was passed. Key in the erosion was the Supreme Court’s ruling in June that states don’t have to participate in the expansion of Medicaid, the state-federal plan for the poor. The Obama administration, in response, issued regulations that “expanded the number of people who will be exempt from paying a penalty for being uninsured relative to our previous expectations,” CBO analysts wrote. Twenty states are so far opposing the expansion according to the Kaiser Family Foundation, a nonprofit health research group based in Menlo Park, California.

      In other news, mental illness in children costs $247 billion annually, a figure on the rise along with the number of kids hospitalized for mood disorders, substance abuse and other psychiatric disorders, according to a U.S. report. As many as 1 in 5 children ages 3 to 17 years old has a mentally illness, with attention deficit hyperactivity disorder as the most prevalent diagnosis, according to the report from the Centers for Disease Control and Prevention. The rate of children hospitalized for mood disorders increased 80% from 1997 to 2010, the report said, citing a U.S. study from that year. The CDC report draws on a number of U.S. surveys that collect data on children’s mental health. The Atlanta-based agency uses the report to mark the prevalence of the disorders and promote public health initiatives to treat and prevent them. The report released last week found that suicide, often stemming from mental illness, was the second-leading cause of death in 2010 among adolescents ages 12 to 17. About 7% of children had ADHD, a syndrome in which people have trouble paying attention, act impulsively or are overly active. The prevalence of ADHD increased 3% each year from 1997 to 2006 in one survey; in another, there was a 21.8% total increase in 2007 from 2003.

FDA/EMA ROUNDUP -- Bayer AG (Leverkusen DEU) and its development partner Algeta ASA (Oslo NOR) won approval from the FDA for a prostate cancer drug that could eventually generate more than 1 billion euros ($1.31 billion) in annual sales. The FDA, which has reviewed Xofigo under its priority program, said the injection is cleared for treatment of bone metastases in men whose cancer has spread after receiving medical or surgical therapy to lower testosterone. Bayer licensed Xofigo, also called radium-223 dichloride, from Norway’s Algeta in 2009 and the two companies will co-promote the injection in the U.S. Bayer has also requested approval for the drug in Europe, where it would market the drug alone. ($1 = 0.7641 euros)

     Elsewhere, Biogen Idec Inc. (Weston MA) said the FDA is reviewing its experimental drug Eloctate as a treatment for hemophilia A. Biogen asked the FDA to review the drug in March, and the FDA has accepted that application. Eloctate is intended to be injected once or twice a week, making it a longer-lasting treatment for the condition. Other treatments are taken three or four times a week. Hemophilia is a rare, inherited disease that affects blood clotting. Hemophilia A occurs in approximately one out of every 5,000 male births. Those with the disease don’t have enough of a blood clotting protein called factor VIII. In March the FDA started a review of Biogen’s drug Alprolix as a treatment for hemophilia B, which is less common and is caused by a different deficiency. Both reviews are expected to take 10 months.

      Roche Holding AG (Basel CHE), the world’s biggest maker of cancer drugs, won FDA approval to sell a gene mutation test that can help doctors pinpoint patients’ likelihood to respond to a popular treatment for lung cancer. The diagnostic detects epidermal growth factor receptor gene mutations, and can be used as a companion with Roche and Astellas Pharma Inc.’s drug Tarceva as a first-line cancer treatment. The FDA approval includes the test and the expanded use of Tarceva as an initial treatment for patients with non-small cell lung cancer that has spread in the body and have certain EGFR mutations. Non-small cell lung cancer accounts for 85% of lung cancers, the FDA said.

      Drug developer Seattle Genetics Inc. (Bothell WA) said the FDA has accepted its application to market the lymphatic cancer treatment Adcetris for some additional uses. The company is seeking approval for Adcetris to be used in treating patients who had previously taken the drug, stopped and then saw their disease progress or relapse. It also wants approval for Adcetris to be used in treatments that extend beyond 16 cycles of the therapy. Seattle Genetics expects the FDA to make a decision by Sept. 14. Adcetris is the company’s only marketed product, and it already is approved to treat two types of lymphoma. Seattle Genetics shares closed the week off 29 cents, or 1%, at $36.70. The stock has climbed more than 60% so far this year and hit a 52-week high of $39 last month.

      Cubist Pharmaceuticals Inc. (Lexington MA) received fast-track status for an experimental antibiotic regimen as a treatment for three types of infections. The company is studying a combination of ceftolozane and tazobactam as a treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia as well as complicated urinary-tract infections. In February, the FDA granted fast-track status for the drug regimen as a treatment for complicated intra-abdominal infections. Fast-track status gives companies extra meetings and correspondence with regulators throughout the review process, and it allows the drugmaker to submit data as it compiles it. The company's shares closed the week up 83 cents, or 2%, at $48.00.

      In other news, the FDA warned doctors and pharmacists to avoid drugs made by a Florida specialty pharmacy called The Compounding Shop (St. Petersburg FL), due to potential safety problems uncovered by health inspectors. The pharmacy has agreed to recall all of its sterile drugs and is in the process of notifying customers, the FDA said in a statement. The agency said healthcare professionals should quarantine drugs from the company and not administer them to patients. The Compounding Shop is a compounding pharmacy, which means it mixes custom formulations of drugs to meet doctors' specifications. In recent weeks the FDA has cracked down on compounding pharmacies across the country, triggering several national recalls. The wave of inspections comes in the wake of a nationwide fungal meningitis outbreak last year tied to contaminated drugs from a Massachusetts pharmacy. The outbreak sickened more than 700 Americans and killed more than 50 others.

      The FDA issued a warning to doctors and women of child-bearing age that half-a-dozen medications used to treat migraine headaches can decrease children's intelligence if taken while their mothers are pregnant. The agency said the drugs, including Depakote and Depacon, should never be taken by pregnant women for the prevention of migraine headaches. The pills, which all contain the ingredient valproate sodium, already carry a boxed warning about the risk of birth defects. But the FDA said it is adding new warnings to the drugs after a study showed they decreased IQ scores in children whose mothers took them while pregnant.

      Endo Health Solutions Inc. (Malvern PA) lost an effort to stop U.S. sales of generic versions of its extended-release painkiller that don't have tamper-resistant qualities. The FDA's decision Friday means generic versions of Endo's older Opana ER without abuse-deterrent technology will remain on the market. Endo sought a determination from the FDA that the original Opana ER was taken off the market for safety reasons, a determination that would have meant less competition for its newer version. The FDA declined to do so and instead criticized properties of the new Opana ER that were supposed to make the drug resistant to injection and snorting. Endo closed the week off $2.61, or 7%, at $34.97. Impax Laboratories Inc. (Hayward CA), the maker of a generic version of Opana ER, closed the week up 40 cents, or 2%, at $17.40 on the news.

      And in Europe, Bayer AG’s (Leverkusen DEU) acne pill Diane 35 and its generic versions are safe to use in certain women when other options have failed, the European Medicines Agency said on Friday. Following a formal safety review, conducted at the request of French authorities, the agency concluded that the benefits outweighed the risks--provided measures were taken to minimize the chance of blood clots forming in veins and arteries. The medicines should be used solely in the treatment of moderate to severe acne in women of reproductive age and only when alternative treatments, such as topical therapy and oral antibiotic treatment, have failed. French authorities suspended sales of drugs in January after four deaths over the past 25 years were linked to their use.

MEDICAL STOCK SPOTLIGHT -- Alimera Sciences Inc. (Nasdaq) led advancing issues, leaping $1.07, or 34% over the week, to $4.18. The biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals has been on a recent run-up. On May 1st, Alimera announced that its recent resubmission of the New Drug Application for ILUVIEN has been acknowledged as received by the U.S. Food and Drug Administration as a complete class 2 response to the FDA’s November 2011 letter. ILUVIEN is Alimera’s sustained release intravitreal implant that delivers sub-microgram levels of fluocinolone acetonide for up to 36 months for the treatment of chronic diabetic macular edema (DME). Alpharetta, GA-based Alimera is focused on diseases affecting the back of the eye, or retina.

      Elsewhere, Insmed Inc. (Nasdaq) surged $2.55, or 31%, to $10.90, a new 52-week high, after Lazard Capital Markets issued a “buy” rating on the stock with a price target of $21. Several other analysts have also recently commented on the stock. The stock’s 50-day moving average is currently $7.05. The company’s market cap is $333.4 million. Monmouth Junction, NJ-based Insmed is a biopharmaceutical company specializing in recombinant protein drug development.

      Acadia Pharmaceuticals Inc. (Nasdaq) jumped $1.25, or 10%, to $13.27 after a Roth Capital Partners analyst said he thinks the company has become a more attractive target for a takeover. Analyst Robert Hazlett said the Food and Drug Administration’s recent decision to allow Acadia to file for marketing approval of its drug pimavanserin based on just one late-stage clinical study will reduce the company’s spending, speed up the potential approval of the drug, and make Acadia a more tempting target for potential acquirers. San Diego, CA-based Acadia does not have any approved products. Its most advanced drug is pimavanserin, which is intended to treat psychosis associated with Parkinson’s disease. The shares are up about 50% since April 10, and their value has risen more than eightfold in the past 12 months.

      And Invacare Corp. (NYSE) advanced 6% to $14.56 after the company said it is making progress in a government review of an Ohio facility. The FDA had limited production at the plant because of manufacturing problems. Elyria, OH-based Invacare, which makes wheelchairs, crutches and motorized scooters, said the FDA accepted the results of the first audit of the manufacturing facility, which is in Elyria. That means the facility can resume manufacturing and distributing parts to other Invacare plants. Two other audits need to be completed before the facility can resume full operations.

      But GenVec Inc. (Nasdaq) plunged 45% to $0.66 after reporting first quarter results that disappointed investors.  Gaithersburg, MD-based GenVec’s net loss was $3.0 million (or $0.24 per share) on revenues of $1.2 million for the three months ended March 31, 2013. This compares to a net loss of $3.2 million (or $0.25 per share) on revenues of $3.2 million in the same period in the prior year. GenVec ended the first quarter of 2013 with $11.8 million in cash, cash equivalents, and investments. Revenues for the first quarter were $1.2 million, a 62% decrease as compared to $3.2 million in the comparable prior year period. GenVec is a biopharmaceutical company whose development programs address therapeutic areas such as hearing loss and balance disorders as well as vaccines against infectious diseases.

      And Oncothyreon Inc. (Nasdaq) fell 21% to $1.99 after the drug developer announced new clinical trial data about an experimental lung cancer treatment that failed to improve overall survival rate. Seattle, WA-based Oncothyreon said that it identified some patients who appeared to live longer after treatment with Stimuvax. In a group of 806 patients who received a combination of chemotherapy and radiation at the same time, patients who took L-BLP25 lived for 30.8 months on average. That compares with 20.6 months for patients who were given a placebo. About two-thirds of the patients in the trial were treated that way. The rest received chemotherapy and then radiation. The patients had inoperable, locally advanced non-small cell lung cancer.

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