Biotech Weekly Commentary (June 4 – June 8)

Put the latest biotech news in context with this week’s Biotech Commentary report, generated by Thomson Reuters IR Advisory Services analysts.  Learn about relevant clinical and regulatory news, information on partnerships and financings, notable sell-side upgrades, downgrades and price target changes, earnings recaps, and informative sector articles and videos.  Read the report.  Interested in getting similar commentaries on a daily basis – before the market opens and following the close?  Leave a comment to let us know.

 

Week of June 4– June 8, 2012

Biotechnology indices finished higher  with major US averages. Clinical updates at ASCO were in sector focus. For the week, the BTK advanced 2.44% to 1415.85, and the NBI rose 3.43% to 1283.53.

 

REGULATORY

Merck announced the FDA issued a CRL regarding the NDA for ridaforolimus in metastatic soft tissue or bone sarcoma. Merck rose 1.07% to $37.90 on Wednesday. Ariad Pharmaceuticals, which is partnered with Merck on ridaforolimus, gained 2.78% to $16.65.

GlaxoSmithKline and XenoPort announced the FDA approved Horizant ER Tablets in postherpetic neuralgia (PHN) in adults. Glaxo slipped 0.25% to $44.27 on Thursday, and XenoPort dropped 9.56%.

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Biotech Weekly Commentary (May 28 – June 1)

Put the latest biotech news in context with this week’s Biotech Commentary report, generated by Thomson Reuters IR Advisory Services analysts.  Learn about relevant clinical and regulatory news, information on partnerships and financings, notable sell-side upgrades, downgrades and price target changes, earnings recaps, and informative sector articles and videos.  Read the report.  Interested in getting similar commentaries on a daily basis – before the market opens and following the close?  Leave a comment to let us know.

 

Week of May 28– June 1, 2012

Declines in biotechnology indices exceeded those in major US averages. For the week, the BTK receded 5.85% to 1382.11, and the NBI fell 4.53% to 1240.98. Each finished at the lowest levels since mid-April.

 

REGULATORY

Janssen Therapeutics, a division of Janssen Products, announced the FDA issued a CRL for a sNDA for an 800mg tablet of PREZISTA. PREZISTA is approved for once-daily oral administration of 800mg — two 400mg tablets — for the treatment of HIV-1 in treatment-naive and treatment-experienced adult patients with no darunavir resistance-associated mutations.

Exelixis announced on Wednesday it completed the filing of its rolling NDA with the FDA for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer. Exelixis slipped 0.65% to $4.59.

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Biotech Weekly Commentary (May 21 – May 25)

Put the latest biotech news in context with this week’s Biotech Commentary report, generated by Thomson Reuters IR Advisory Services analysts.  Learn about relevant clinical and regulatory news, information on partnerships and financings, notable sell-side upgrades, downgrades and price target changes, earnings recaps, and informative sector articles and videos.  Read the report.  Interested in getting similar commentaries on a daily basis – before the market opens and following the close?  Leave a comment to let us know.

 

Week of May 21– May 25, 2012

Biotechnology gains outpaced those in major US averages. For the week, the BTK rose 3.32% to 1467.97, and the NBI advanced 3.91% to 1299.90.

 

REGULATORY

Merck announced the FDA approved a labeling update for ISENTRESS (raltegravir) Film-coated Tablets to include 156-week data from the STARTMRK study with ISENTRESS in combination therapy compared to efavirenz in combination therapy in previously untreated (treatment-naïve) adult HIV-1-infected patients. Merck fell 0.58% to $37.60 on Monday.

Vertex Pharmaceuticals announced on Friday the CHMP issued a positive opinion by consensus recommending the approval of KALYDECO for people with CF ages 6 and older who have at least one copy of the G551D mutation in the CF transmembrane conductance regulator gene. Vertex rose 1.19% to $64.85.

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Biotech Weekly Commentary (May 14 – May 18)

Put the latest biotech news in context with this week’s Biotech Commentary report, generated by Thomson Reuters IR Advisory Services analysts.  Learn about relevant clinical and regulatory news, information on partnerships and financings, notable sell-side upgrades, downgrades and price target changes, earnings recaps, and informative sector articles and videos.  Read the report.  Interested in getting similar commentaries on a daily basis – before the market opens and following the close?  Leave a comment to let us know.

 

Week of May 14– May 18, 2012

Biotechnology underperformed major U.S. averages. Investor de-risking on macro-economic uncertainty sharply impacted the sector late in the week. Meanwhile ASCO abstracts and the Bank of America Merrill Lynch Healthcare Conference received attention. For the week, the BTK fell 6.03% to 1420.72, and the NBI declined 4.75% to 1251.04.

 

REGULATORY

OraSure Technologies announced the FDA Blood Products Advisory Committee provided a unanimous positive recommendation for the company’s OraQuick In-Home HIV Test. OraSure rallied 20.33% to $10.95 on Wednesday.

Achillion Pharmaceuticals announced the receipt of a Fast Track designation from the FDA for ACH-3102 as part of an interferon-free regimen for the treatment of chronic HCV. Achillion fell 1.02% to $6.82 on Tuesday.

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Biotech Weekly Commentary (Apr. 30 – May 4)

Put the latest biotech news in context with this week’s Biotech Commentary report, generated by Thomson Reuters IR Advisory Services analysts.  Learn about relevant clinical and regulatory news, information on partnerships and financings, notable sell-side upgrades, downgrades and price target changes, earnings recaps, and informative sector articles and videos.  Read the report.  Interested in getting similar commentaries on a daily basis – before the market opens and following the close?  Leave a comment to let us know.

 

Week of Apr. 30– May 4, 2012

Sector indices fell with major US averages. For the week, the BTK declined 1.96% to 1451.84, and the NBI slipped 3.36% to 1265.03.

 

REGULATORY

Reuters reported on Thursday GlaxoSmithKline and Human Genome Sciences’ lupus drug Benlysta was rejected by Germany’s healthcare cost watchdog. The negative draft benefit assessment from the German Institute for Quality and Efficiency in Health Care follows a similar rebuff from Britain’s NICE. Glaxo rose 0.47% to $46.89, and Human Genome rose 0.28% to $14.55.

Alexza Pharmaceuticals announced it received a CRL from the FDA regarding its NDA for ADASUVE inhalation powder, 5 mg and 10 mg. ADASUVE is being developed for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Alexza fell 19.67% to $0.49 on Friday.

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Biotech Weekly Commentary (Apr. 23 – Apr. 27)

Put the latest biotech news in context with this week’s Biotech Commentary report, generated by Thomson Reuters IR Advisory Services analysts.  Learn about relevant clinical and regulatory news, information on partnerships and financings, notable sell-side upgrades, downgrades and price target changes, earnings recaps, and informative sector articles and videos.  Read the report.  Interested in getting similar commentaries on a daily basis – before the market opens and following the close?  Leave a comment to let us know.

 

Week of Apr. 23– Apr. 27, 2012

Sector indices advanced with earnings in focus. Gains in the BTK and NBI exceeded those in the major US averages. For the week, the BTK advanced 3.51% to 1480.90, and the NBI climbed 3.33% to 1308.96.

 

REGULATORY

Reuters reported on Friday U.S. health regulators approved Vivus’ Avanafil treatment for erectile dysfunction. Vivus gained 2.95% to $25.15. 

Amgen announced on Friday the FDA has issued a CRL for the sBLA for XGEVA (denosumab) to treat men with castration-resistant prostate cancer at high risk of developing bone metastases.  The FDA determined that the effect on bone metastases-free survival was of insufficient magnitude to outweigh the risks (including osteonecrosis of the jaw) of XGEVA in the intended population, and requested data from an adequate and well-controlled trial(s) demonstrating a favorable risk-benefit profile for XGEVA that is generalizable to the U.S. population. Amgen climbed 1.20% to $71.64.

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Biotech Weekly Commentary (Apr. 16 – Apr. 20)

Put the latest biotech news in context with this week’s Biotech Commentary report, generated by Thomson Reuters IR Advisory Services analysts.  Learn about relevant clinical and regulatory news, information on partnerships and financings, notable sell-side upgrades, downgrades and price target changes, earnings recaps, and informative sector articles and videos.  Read the report.  Interested in getting similar commentaries on a daily basis – before the market opens and following the close?  Leave a comment to let us know.

 

Week of Apr. 16– Apr. 20, 2012

Sector indices outperformed majorUSaverages, fueled late in the week by M&A newsflow and clinical pipeline updates at EASL. For the week, the BTK rallied 8.10% to 1430.56, and the NBI climbed 3.24% to 1266.72.

 

REGULATORY

AstraZeneca and Bristol-Myers Squibb announced the CHMP recommended the approval of FORXIGA (dapagliflozin) tablets for the treatment of Type II diabetes, as an adjunct to diet and exercise, in combination with other glucose-lowering medicinal products including insulin, and as a monotherapy in metformin intolerant patients. AstraZeneca gained 1.83% to $38.73 on Friday, and Bristol-Myers Squibb rose 0.88% to $34.23.

Novartis announced the CHMP adopted a positive opinion for Jakavi (INC424, ruxolitinib) for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. In addition, the company announced that the CHMP confirmed a positive benefit-risk profile of once-daily oral Gilenya (fingolimod). Novartis and the CHMP have agreed to recommended updates to the product information in the EU in order to provide further guidance to healthcare providers regarding treatment initiation with Gilenya in MS patients. Novartis rose 1.64% to $56.38 on Friday.

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Biotech Weekly Commentary (Apr. 9 – Apr. 13)

Put the latest biotech news in context with this week’s Biotech Commentary report, generated by Thomson Reuters IR Advisory Services analysts.  Learn about relevant clinical and regulatory news, information on partnerships and financings, notable sell-side upgrades, downgrades and price target changes, earnings recaps, and informative sector articles and videos.  Read the report.  Interested in getting similar commentaries on a daily basis – before the market opens and following the close?  Leave a comment to let us know.

 

Week of Apr. 9– Apr. 13, 2012

Sector indices traced sharply lower, losses exceeding those of majorUSaverages. For the week, the BTK fell 5.72% to 1323.61, and the NBI declined 4.62% to 1226.94.

 

REGULATORY

ViroPharma announced the FDA denied the citizen petition filed by ViroPharma on March 17, 2006 related to the FDA’s proposed in vitro method for determining bioequivalence of ANDAs referencing Vancocin Capsules.  The FDA also informed ViroPharma the recent sNDA for Vancocin approved December 14, 2011 would not qualify for three additional years of exclusivity based on the agency’s assertion that in order for an sNDA for an old antibiotic such as Vancocin to be eligible for a grant of exclusivity, it must be a significant new use or indication. The FDA also indicated it is approving three ANDA’s for generic vancomycin capsules.  ViroPharma fell 21.57% to $22.44 on Tuesday.

Reuters reported Novo Nordisk received a product label update for diabetes drug Victoza to include data showing superior efficacy when compared with rival drug Januvia from Merck. The label update included approval of combination therapy with basal insulin for the treatment of adults with Type II diabetes. Novo Nordisk slid 0.62% to $145.00 on Monday.

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Biotech Weekly Commentary (Apr. 2 – Apr. 6)

Put the latest biotech news in context with this week’s Biotech Commentary report, generated by Thomson Reuters IR Advisory Services analysts.  Learn about relevant clinical and regulatory news, information on partnerships and financings, notable sell-side upgrades, downgrades and price target changes, earnings recaps, and informative sector articles and videos.  Read the report.  Interested in getting similar commentaries on a daily basis – before the market opens and following the close?  Leave a comment to let us know.

 

Week of Apr. 2– Apr. 6, 2012

Sector indices finished mixed amid broad declines in majorUSaverages. For the week, the BTK fell 0.64% to 1403.92, and the NBI climbed 0.41% to 1286.39.

 

REGULATORY

InterMune reported on Friday the Transparency Commission of the French National Health Authority issued a favorable opinion for the reimbursement of Esbriet (pirfenidone) by French National Health Insurance.  InterMune rallied 10.17% to $15.28.

Reuters reported on Wednesday the FDA issued a recall of Thoratec’s HeartMate II pump after finding a key part of the surgical procedure was omitted from the instructions, which could lead to serious side effects or even death. Thoratec declined 4.43% to $32.83.

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Biotech Weekly Commentary (Mar. 19 – Mar. 23)

Put the latest biotech news in context with this week’s Biotech Commentary report, generated by Thomson Reuters IR Advisory Services analysts.  Learn about relevant clinical and regulatory news, information on partnerships and financings, notable sell-side upgrades, downgrades and price target changes, earnings recaps, and informative sector articles and videos.  Read the report.  Interested in getting similar commentaries on a daily basis – before the market opens and following the close?  Leave a comment to let us know.

 

Week of Mar. 19– Mar. 23, 2012

Biotech indices and majorU.S.averages finished the week mixed. The BTK fell 0.05% to 1340.30, and the NBI rose 0.81% to 1265.41.

 

REGULATORY

Reuters reported an FDA panel recommended GlaxoSmithKline’s Votrient for treatment of advanced soft-tissue sarcoma. The FDA Advisory Committee of outside experts voted 11-2 to find that the drug’s ability to improve short-term survival without worsening symptoms in patients who receive chemotherapy outweighed adverse risks and a lack of evidence that it can extend overall survival.

Merck and ARIAD Pharmaceuticals announced the FDA’s ODAC voted 13 to 1 against the use of the investigational agent ridaforolimus as maintenance therapy for patients with metastatic soft-tissue sarcoma or bone sarcoma whose disease has not progressed after at least four cycles of chemotherapy. Merck fell 0.16% to $37.70 on Wednesday, and ARIAD rose 1.46% to $15.27.

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