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 (May 7 – May 11)

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 7– May 11, 2012

Sector gains outpaced those in major US averages. A series of positive regulatory rulings and clinical read-outs provided industry-specific strength. Mid-cap company earnings, several of which provided visibility into drug launch progress, were mixed. For the week, the BTK climbed 4.14% to 1511.91, and the NBI rose 3.83% to 1313.48.

 

REGULATORY

Pfizer announced on Wednesday the Arthritis Advisory Committee to the FDA voted 8-2 to recommend approval of tofacitinib in adult patients with moderately to severely active RA. The FDA has provided an anticipated PDUFA action date in August 2012. Pfizer rose 1.13% at $22.45.

Reuters reported an experimental obesity pill from Arena Pharmaceuticals won a U.S. panel’s support. A panel of outside experts to the FDA voted 18 to 2, with one abstention, to recommend approval of lorcaserin. The FDA will make a final decision by June 27. Arena soared 73.77% to $6.36 on Friday.

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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 (Jan. 16 – Jan. 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 Jan. 16 – Jan. 20, 2011

Biotech traded softly relative to a broader market advance this week. The BTK rose 0.05% to 1242.40 and the NBI gained 0.76% to 1174.93. 

 

REGULATORY

Novartis announced that it received regulatory approval in China from the SFDA for Lucentis (ranibizumab) to treat wet (neovascular) age-related macular degeneration, and is launching Galvus (vildagliptin), an oral treatment for patients with Type II diabetes approved in China as an add-on to metformin, the standard of care. Novartis rose 2.04% to $57.43 on Wednesday. Later in the week, the EMA advised doctors to continuously monitor patients for six hours after giving them a first dose of Novartis’ multiple sclerosis drug Gilenya.  Novartis shares fell 5.52% to $55.11 on Friday.

On Thursday, Bristol-Myers Squibb and AstraZeneca announced that the FDA has issued a complete response letter regarding the NDA for investigational compound dapagliflozin for the treatment of Type II diabetes in adults. Bristol-Myers Squibb fell 3.02% to $32.71, and AstraZeneca declined 1.41% to $47.52.

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Biotech Weekly Commentary (Jan. 9 – Jan. 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 Jan. 9 – Jan. 13, 2011

Biotech markedly outperformed the broader markets this week, with the BTK gaining 6.81% to 1242.07 and the NBI rising 4.58% to 1166.02. 

 

REGULATORY

VIVUS announced that following recent discussions with FDA officials, the company has been asked to remove the Qnexa contraindication for women of childbearing potential contained in the proposed label.  Qnexa would remain contraindicated for women who are pregnant.  Included with the resubmission of the Qnexa NDA was a proposed Risk Evaluation and Mitigation Strategy, or REMS.  The company is currently revising its proposed REMS based on this change in the contraindication and plans to discuss the details of the Qnexa REMS during the upcoming Endocrinologic and Metabolic Drugs Advisory Committee.  Shares rose 14.67% to $11.65 on Monday.

Arena Pharmaceuticals and Eisai announced that the FDA has accepted for filing and review Arena’s resubmission of the NDA for lorcaserin. The FDA considers the resubmission a complete, class 2 response, and assigned a new PDUFA target date of June 27, 2012. Arena increased 9.03% to $1.75 on Tuesday.

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