FDA to speed review of generic versions of opioid overdose antidote

8 July 2019 - The US FDA on Monday said it would prioritise and expedite the review of generic versions ...

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Trump rule requiring drug prices in TV ads blocked

8 July 2019 - Federal judge sides with companies, saying regulation would violate free speech. ...

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ADMA Biologics receives FDA approval for license transfers for Bivigam and Nabi-HB

8 July 2019 - All aspects of the Biotest Therapy Business Unit acquisition are successfully completed. ...

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Prevail Therapeutics receives U.S. FDA fast track designation for PR001 for the treatment of Parkinson’s disease patients with a GBA1 mutation

8 July 2019 - Company plans to initiate Phase 1/2 clinical trial in the second half of 2019. ...

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Plan on more pharma mega-mergers

6 July 2019 - With a drought in new blockbuster drugs, generating growth has become a challenge. ...

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Fast-track drug approval, designed for emergencies, is now routine

5 July 2019 - Three-quarters of new drugs get an expedited regulatory review, thrusting families and doctors into a new world ...

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Grifols announces FDA approval of Xembify, 20% subcutaneous immunoglobulin for primary immunodeficiencies

4 July 2019 - Xembify is Grifols’ first 20% subcutaneous immunoglobulin for the treatment of primary immunodeficiencies. ...

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Attempt to replicate clinical trials with real world data generates real world criticism, too

3 July 2019 - It’s one of the most seductive ideas in medicine: that “real-world evidence,” including data from electronic ...

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Karyopharm Therapeutics prices blood cancer treatment after FDA approval

4 July 2019 - Karyopharm Therapeutics has set a list-price for its blood cancer treatment Xpovio at $22,000 per month, ...

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RedHill Biopharma announces FDA acceptance of new drug application for Talicia

3 July 2019 - U.S. FDA accepts NDA for priority review. ...

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FDA accepts new drug application for INSYS Therapeutics’ naloxone nasal spray for the emergency treatment of known or suspected opioid overdose

3 July 2019 - INSYS Therapeutics announced today that its new drug application to the U.S. FDA for its investigational, proprietary ...

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FDA approves new treatment for refractory multiple myeloma

3 July 2019 - Today, the U.S. FDA granted accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone ...

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Some insurers are pushing back on the high price for a Novartis gene therapy

3 July 2019 - Barely a month after Novartis won U.S. regulatory approval for its gene therapy — the most ...

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Validation of patient reported outcomes: a low bar

3 July 2019 - It used to be that if we wanted to assess a patient’s back pain, we would evaluate ...

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Innovation prizes to support cell and gene therapy

2 July 2019 - Personalised cell and gene therapy represent a fundamental therapeutic revolution.  ...

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