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19:13 EST 24th November 2017 | BioPortfolio

FDA publishes new draft guidance for ADHD generic

In October 2017, the US Food and Drug Administration (FDA) issued new product-specific draft guidance for generic methylphenidate oral extended-release tablets.

CannaRoyalty Welcomes Favourable TMX Group Update Regarding Issuers with U.S. Marijuana-Related Activities

OTTAWA, ONTARIO -- (Marketwired) -- 11/24/17 -- CannaRoyalty Corp. (CSE: CRZ)(CSE: CRZ.CN)(CNSX: CRZ)(OTCQX: CNNRF) ("CannaRoyalty" or the "Company"), commented on TMX Group's ("TMX") press release TMX Group Provides Update Regarding Regulatory Engagement, dated November 24, 2017. Media reports in August 2017 speculated that there might be a Canadian Depository for Securities ("CDS") ban on the ...

US FDA guidance aims to encourage generic abuse-deterrent opioids

The US FDA has issued final guidance for evaluating the abuse deterrence of generic solid oral opioid drug products in efforts to deter abuse.

Regulating GMOs: time to move forward

It’s time to move regulation of genetic modification forward. The current set-up is temporary and unsound. We use a risk-based approach for almost everything because that’s what makes sense. But New Zealand takes an arbitrary approach to genetic modification. So we ‘ban’ a technique that evidence shows there is no special risk in using. That poor […] The post Regulating GMOs: ti...

#jobs #lifescience Medical Training and Quality Compliance Owner

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Medical Training and Quality Compliance Owner .MA-Cambridge, Job Description: Reporting to the Head Global Medical Affairs Operations, the Medical Training and Quality Compliance Owner will be a key … Continue reading → Cet article #jobs #lifescience Medical Traini...

CannaRoyalty Commends Health Canada's Proposed Approach for the Regulation of Cannabis Products

OTTAWA, ONTARIO -- (Marketwired) -- 11/23/17 -- CannaRoyalty Corp. (CSE: CRZ)(CSE: CRZ.CN)(CSNX: CRZ)(OTCQX: CNNRF) ("CannaRoyalty" or the "Company"), today commented on Health Canada's Proposed Approach to the Regulation of Cannabis (the "Proposed Regulations"), which was released to the public on November 22, 2017. The Proposed Regulations contemplate a variety of cannabis product forms not cu...

Geratherm Medical AG: Preliminary announcement of the publication of quarterly reports and quarterly/interim statements

Geratherm Medical AG / Preliminary announcement on the disclosure of financial statements 22.11.2017 / 08:21 Preliminary announcement of the publication of quarterly reports and quarterly/interim statements transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. -----------------------------------------------------------------------...

Acasti Pharma Clarifies Term of Proposed Strategic Partnership with Leading China Pharmaceutical Company

LAVAL, QUEBEC -- (Marketwired) -- 11/22/17 -- Acasti Pharma Inc. (NASDAQ: ACST)(TSX VENTURE: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, today clarified the proposed term of the transaction contemplated by its recently announced no...

Tetra Bio-Pharma's Business Model and Commercialization Strategy In Line with the Canadian Government's Proposed Approach to the Regulation of Cannabis

OTTAWA, ONTARIO -- (Marketwired) -- 11/22/17 -- Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX VENTURE: TBP)(OTCQB: TBPMF), a global leader in cannabinoid-based drug development and discovery, today announced that the Canadian Government's Proposed Approach to the Regulation of Cannabis further confirms the strategic direction of its business model, and that the company is in an excellent...

Anthem Announces Pricing of its Tender Offer for Any and All of its 7.000% Notes due 2019

Anthem, Inc. (“Anthem”) announced today the pricing of its previously announced cash tender offer (the “Any and All Notes Offer”) for any and all of its outstanding 7.000% Notes due 2019 (the “Any and All Notes”). The terms and conditions of the Any and All Notes Offer are described in the offer to purchase dated November 14, 2017 (the “Off...

Lilly Confirms Date and Conference Call for 2018 Financial Guidance Announcement

Lilly Confirms Date and Conference Call for 2018 Financial Guidance Announcement

Clearwater Compliance CEO Bob Chaput to Speak at Cayman Captive Conference

Healthcare Cyber Risk Management Leader Addresses Insuring Cyber Exposure Through a Captive Clearwater Compliance, a top-ranked, award-winning provider of healthcare

Walgreens Boots Alliance Recommends Stockholders Reject Mini-Tender Offer by TRC Capital Corporation

Walgreens Boots Alliance, Inc. (Nasdaq: WBA) today announced it has received notice of an unsolicited mini-tender offer by TRC Capital Corporation to purchase up to 2 million shares of Walgreens Boots Alliance common stock at a price of $67.88 per share in cash. TRC Capital’s offering price is 4.38 percent below the closing price per share of Walgreens B...

FDA Issues Final and Draft Regenerative Medicine Guidance Documents

The FDA has issued two final guidances and two draft guidances, all designed to articulate the agency’s approach to developing and overseeing novel cellular therapies and other regenerative medicine products. The agency said its suite of four guidance documents constituted a risk-based and science-based policy framework approach designed to support innovative product development while clarif...

APIC to CDC: Need for Legionella Guidance

In light of numerous Legionnaires’ disease outbreaks in the last few years, the CDC has asked clinicians in the field what should be emphasized in revised guidance to reduce the growth and transmission of Legionella spp. in healthcare water systems.

Disclosure of Errors Not Documented — Even if Patient Seriously Harmed

Very few disclosures of medical errors or apologies to the patient or relatives were documented in medical records, found a recent analysis of malpractice claims.

FCRA Sets Strict Limits on Background Screens

The federal Fair Credit Reporting Act doesn’t apply to background checks conducted in-house, but some state and local laws do. Employers must know what laws govern background checks in their particular state.

Diffusion Pharmaceuticals Regains Compliance with Nasdaq Capital Market Minimum Equity Rule

CHARLOTTESVILLE, Va., Nov. 20, 2017 (GLOBE NEWSWIRE) -- Diffusion Pharmaceuticals Inc. (Nasdaq:DFFN) (“Diffusion” or “the Company”), is a clinical-stage biotechnology company focused on extending the life expectancy of cancer patients using the novel small molecule trans sodium crocetinate (TSC) in conjunction with standard radiation and chemotherapy. The Company today announced that ...

Acasti Pharma Announces Development and Commercialization Discussions Progressing with a Leading China Pharmaceutical Partner

LAVAL, QUEBEC -- (Marketwired) -- 11/20/17 -- Acasti Pharma Inc. (NASDAQ: ACST)(TSX VENTURE: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, today announced that the company recently entered into a non-binding term sheet with a leading...

Trillium Therapeutics' TTI-2341 EGFR Inhibitor Program Featured at the Society for Neuro-Oncology 22nd Annual Meeting

TORONTO, ONTARIO -- (Marketwired) -- 11/20/17 -- Trillium Therapeutics Inc. (NASDAQ: TRIL)(TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, announced today that new preclinical data for its novel covalent EGFR inhibitor were presented at the Society for Neuro-Oncology 22nd Annual Meeting, November 16-19, in San Francisco. Poster Pr...

Russell Investments Group Ltd. Sells 52,670 Shares of Cardinal Health, Inc.

Russell Investments Group Ltd. cut its stake in Cardinal Health, Inc. by 5.9% in the 3rd quarter, according to the company in its most recent disclosure with the SEC. The institutional investor owned 842,364 shares of the company's stock after selling 52,670 shares during the quarter.

#jobs #lifescience Compliance Examiner Professional

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Compliance Examiner Professional .CA-Alameda, • The Technician will perform routine testing of medical devices in order to replicate customer complaints and if applicable identify the root cause of … Continue reading → Cet article #jobs #lifescience Compliance Ex...

Wilmer Lawyer, Trump Pick for Trade Compliance Head, Reveals Salary, Clients

A Wilmer Cutler Pickering Hale and Dorr counsel in Washington who specializes in regulatory and government affairs plans to divest interests in six major U.S. companies if he's confirmed to lead enforcement and compliance efforts at the U.S. Commerce Department. Kessler said in his ethics agreement he would divest holdings in Bristol-Myers Squibb Co., Ford Motor Co., JPMorgan Chase & Co., ...

Activist Shareholder, the CCO and Compliance

It certainly is one thing for a company to make changes in their compliance program based upon ongoing monitoring, evolving best practices or remediation during an investigation. However, Boards of Directors, Chief Compliance Officers and compliance programs may now face a new source of dynamic tension in the form of activist shareholders.

Tetra Bio-Pharma Inc.: Rx Princeps(TM) Now Available for Patients through Licenced Producer Partner Aphria

OTTAWA, ONTARIO -- (Marketwired) -- 11/16/17 -- Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX VENTURE: TBP)(OTCQB: TBPMF), a global leader in cannabinoid-based drug development and discovery, today announced that Rx Princeps™, unique blend of dried medical cannabis used in its PPP001 clinical trials, is now available through licensed producer Aphria Inc. ("Aphria") under Access to Canna...

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