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Wednesday, September 4, 2019

Bayer says it disagrees with German government’s decision to ban glyphosate

Bayer on Wednesday said it disagreed with a decision by the German government to ban the use of glyphosate from the end of 2023, saying that the substance used in a weedkiller made by its U.S.-based unit Monsanto can be used safely.

“Such a ban would ignore the overwhelming scientific assessments of competent authorities around the world that have determined for more than 40 years that glyphosate can be used safely,” the German chemicals giant said.
Glyphosate is the subject of billion-dollar U.S lawsuits Monsanto faces over claims it causes cancer. Concerns about glyphosate’s safety emerged when a World Health Organization agency concluded in 2015 that it probably causes cancer. Bayer contests this.

Endo up 3% premarket on FDA OK of generic Orafin

Endo International (NASDAQ:ENDP) is up 3% premarket on light volume in reaction to the FDA nod for subsidiary Endo Ventures partner’s Novitium Pharma’s generic version of Swedish Orphan Biovitrum’s (OTCPK:BIOVF) Orafin (nitisinone capsules) for the treatment of hereditary tyrosinemia type 1 (elevated levels of tyrosine in the blood).
Endo unit Par Pharmaceuticals will distribute to specialty pharmacies starting this month.
According the Swedish Orphan Biovitrum, global sales of Orafin are ~$85M.

Stryker to acquire Mobius Imaging for up to $500M

Stryker (NYSE:SYK) has agreed to acquire privately held Mobius Imaging, LLC and its sister company GYS Tech, LLC (doing business as Cardan Robotics) for $370M in upfront cash plus up to $130M in development and commercial milestones.
The company says the transaction provides it with immediate entry into the intraoperative imaging segment and aligns with its implant and navigation offerings.
The deal should close next quarter. It will not have a material impact on Stryker’s net earnings this year.

Mallinckrodt settles federal Questcor inquiry for $15.4M

Mallinckrodt (NYSE:MNK) has finalized the settlement agreement with the U.S. Department of Justice over alleged violations of the False Claims Act by subsidiary Questcor before being acquired by MNK in 2014. The company has agreed to pay $15.4M to resolve the investigation without an admission of wrongdoing.
Shares up 1% premarket on light volume.

Idera teams up with AbbVie in cancer combo therapies

Idera Pharmaceuticals (NASDAQ:IDRA) will collaborate with AbbVie (NYSE:ABBV) on a three-arm Phase 1b open-label clinical trial evaluating combinations of an OX40 agonist (ABBV-368), a TLR-9 agonist (tilsotolimod), chemotherapy (nab-paclitaxel) and/or an anti-programmed cell death 1 (PD-1) antagonist (ABBV-181) stimulate the immune system resulting in anti-tumor responses.
AbbVie will conduct the study while Idera will supply tilsotolimod.
ABBV is up 1% premarket on light volume.

Bristol-Myers teams with drug development accelerator

Bristol-Myers Squibb (NYSE:BMY) has agreed to become a limited partnerwith BioMotiv, a drug development accelerator, aimed at bringing discoveries at academic institutions into the market.
Under the terms of the partnership, the parties will form and fund new companies to develop novel therapeutics in areas of unmet need. BMY will have the option to invest additional capital in selected projects of mutual interest. Specific financial terms are not disclosed.
Shares up 1% premarket on light volume.

USPSTF Advises Meds to Reduce Risk for Primary Breast Cancer

The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians offer risk-reducing medications to women at increased risk for breast cancer and at low risk for adverse medication effects. These recommendations form the basis of a final recommendation statement published in the Sept. 3 issue of the Journal of the American Medical Association.
Heidi D. Nelson, M.D., M.P.H., from the Oregon Health & Science University in Portland, and colleagues reviewed data from 46 studies to update the 2013 USPSTF systematic review on medications to reduce the risk for primary invasive breast cancer.
The researchers found that tamoxifen, raloxifene, and the aromatase inhibitors exemestane and anastrozole correlated with a reduced incidence of invasive breast cancer in placebo-controlled trials (risk ratios, 0.69, 0.44, and 0.45, respectively). Tamoxifen, raloxifene, and aromatase inhibitors were associated with adverse effects that differed between medications, including increased thromboembolic events for tamoxifen and raloxifene versus placebo. Based on these findings, the USPSTF recommends that clinicians offer to prescribe risk-reducing medications to women at increased breast cancer risk and at low risk for adverse medication effects (B recommendation). For women who are not at increased risk, the USPSTF recommends against routine use of risk-reducing medications (D recommendation).
“We all want to find better ways to help prevent breast cancer, and it’s important that clinicians talk with patients about their level of risk and carefully consider the best approach,” USPSTF member Carol M. Mangione, M.D, said in a statement.