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FDA proposes limit for inorganic arsenic in infant rice cereal

RegulatorFDA2016-04-02 12:48 Read   80

The U.S. Food and Drug Administration is taking steps to reduce inorganic arsenic in infant rice cereal, a leading source of arsenic exposure in infants. Relative to body weight, rice intake for infants, primarily through infant rice cereal, is about three times greater than for adults.

Pfizer And Allergan Receive Request For Additional Information From Federal Trade Commission Regarding Proposed Combination

RegulatorPfizer 2016-04-01 10:49 Read   135

The request was fully anticipated as part of the regulatory process; Pfizer and Allergan continue to expect the transaction to close in the second half of 2016

Opdivo edges closer to first haematological cancer indication

RegulatorPlive2016-04-01 10:38 Read   179

The EU drugs regulator has started its review of Bristol-Myers Squibb's PD-1 inhibitor Opdivo in Hodgkin's lymphoma, which could be the first haematological cancer indication for a checkpoint inhibitor drug.

SEC: Biotech Company Misled Investors About New Drug's Status With FDA

RegulatorSEC2016-03-31 12:58 Read   87

The Securities and Exchange Commission today announced fraud charges against a Massachusetts-based biotech company and three former executives for misleading investors about the company’s efforts to obtain Food and Drug Administration (FDA) approval for its flagship developmental drug to treat kidney cancer.

SEC: Biotech Venture Capitalist Stole Investor Funds for Personal Use

RegulatorSEC2016-03-31 11:16 Read   79

The Securities and Exchange Commission today announced that a San Francisco-based biotech venture capitalist has agreed to settle charges that he siphoned money from a fund managed by his firm in order to prop up other struggling businesses he owned and finance his lavish lifestyle.

FDA allows use of investigational test to screen blood donations for Zika virus

RegulatorFDA2016-03-31 10:47 Read   184

The U.S. Food and Drug Administration today announced the availability of an investigational test to screen blood donations for Zika virus. The screening test may be used under an investigational new drug application (IND) for screening donated blood in areas with active mosquito-borne transmission of Zika virus.

Lundbeck and Takeda receive Complete Response Letter by the FDA for Brintellix® (vortioxetine) sNDA

RegulatorGlobenewswire2016-03-29 09:41 Read   455

Takeda Pharmaceutical Company Limited (Takeda) and H. Lundbeck A/S (Lundbeck) today announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) for the supplemental new drug application (sNDA) to include new data in the clinical trials section of the U.S. label of Brintellix® (vortioxetine) for treating certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD).

Novartis wraps up China bribery probe with $25M payment to SEC

RegulatorNovartis2016-03-25 10:46 Read   188

Novartis agreed to fork over $25 million to settle a Securities and Exchange Commission investigation into bribery allegations in China. It's the latest example of corruption claims made against the Swiss drugmaker's operations in Asia.

FDA takes important step to increase the development of, and access to, abuse-deterrent opioids

RegulatorFDA2016-03-25 09:17 Read   181

The U.S. Food and Drug Administration today issued a draft guidance intended to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF) while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug.

IQWiG unimpressed with Cosentyx in two new indications

RegulatorPMLIVE2016-03-24 10:27 Read   165

Germany's cost regulator has decided there is no evidence for an added benefit of Novartis's Cosentyx in ankylosing spondylitis and psoriatic arthritis compared to established drugs.

WHO begs for $4 million to prepare for millions of Zika cases

RegulatorReuters2016-03-23 13:27 Read   93

Findings from a large observational study indicated no significant associations between selective serotonin reuptake inhibitors and increased risk for arrhythmia, myocardial infarction or stroke/transient ischemic attack in adults with depression.

FDA announces enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose and death

RegulatorFDA2016-03-23 09:11 Read   103

In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the U.S. Food and Drug Administration today announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications.