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Genentech's Alecensa granted Breakthrough Therapy Designation

American Pharmacy News Reports | Oct 12, 2016
The FDA has approved Genentech's Alecensa for Breakthrough Therapy Designation.

Genentech's anaplastic lymphoma kinase inhibitor Alecensa has been granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration. Read More »

Bayer and DelSiTech announce Collaboration and Technology License Agreement

American Pharmacy News Reports | Oct 8, 2016
Under the agreement, Bayer will apply DelSiTech's Silica Matrix system to its opthalmology compounds.

Bayer and DelSiTech have issued a joint announcement regarding the signing of a Collaboration and Technology License Agreement. Read More »

EMA accepts Mylan, Biocon MAA for Trastuzumab for review

American Pharmacy News Reports | Sep 28, 2016
Mylan and Biocon's MAA for Trastuzumab has been accepted for review by the EMA.

Mylan N.V. and Biocon Ltd. recently announced that Mylan’s Marketing Authorization Application (MAA) for Trastuzumab has been accepted by the European Medicines Agency (EMA) for review.  Read More »

FDA approves Lannett’s ANDA for Buprenorphine and Naloxone Sublingual Tablets

American Pharmacy News Reports | Sep 22, 2016
The FDA has approved Lannett's ANDA for Buprenorphine and Naloxone Sublingual Tablets.

Lannett Company Inc. announced that the U.S. Food and Drug Administration (FDA) recently approved its Abbreviated New Drug Application (ANDA) for Buprenorphine and Naloxone Sublingual Tablets for the dosing options of 2 mg/0.5 mg and 8 mg/2mg. Read More »

Express Scripts: Lack of competition led to price gouging on EpiPens

John Breslin | Sep 16, 2016

The experience of Mylan, the pharmaceutical company under fire for hiking the price of a life-saving allergy medicine, reinforces the importance of competition in the marketplace, one of the country’s largest pharmacy benefit managers said. Read More »

Morphotek, FCCC enter into SRA

American Pharmacy News Reports | Sep 13, 2016
Morphotek and FCCC have entered into a Sponsored Research Agreement.

Morphotek Inc. recently entered a Sponsored Research Agreement (SRA) along with Fox Chase Cancer Center (FCCC) that will lead to the expansion of its efforts to research how efficient immune-based therapies are in relation to the immunosuppressive effects that are caused by tumor shed antigens. Read More »

PTO rules in favor of Mylan over Copaxone 40 patent

American Pharmacy News Reports | Sep 2, 2016
The PTO has ruled in favor of Mylan regarding a Capoxone 40 patent.

Mylan NV yesterday announced that its inter-parties review (IPR) proceeding in regard to U.S. Patent No. 8,969,302, which is owned by Yeda Research & Development Co. and licensed to Teva Pharmaceuticals, was ruled in its favor of by the U.S. Patent and Trademark Office (PTO) and found unpatentable. Read More »

PinnacleHealth becomes first hospital to implant EDWARDS INTUITY Elite valve

American Pharmacy News Reports | Aug 26, 2016
PinnacleHealth recently became the nation's first hospital to implant the EDWARS INTUITY Elite valve.

PinnacleHealth recently became the first hospital in the United States to implant the EDWARDS INTUITY Elite valve, which is a fast-deployment device for the replacement of a surgical aortic valve. Read More »

Positive results announced in Phase II trial to treat common warts

American Pharmacy News Reports | Aug 24, 2016

Aclaris announces results of A-101 topical solution to treat the common wart. Read More »

Hemispherx Biopharma forms scientific advisory board

American Pharmacy News Reports | Aug 22, 2016

The board members will use their expertise to guide the company and advance its drug development programs. Read More »

FDA committees recommend approval of Egalet’s ARYMO ER

American Pharmacy News Reports | Aug 9, 2016
The FDA's Drug Safety and Risk Management Advisory Committee has voted to recommend Egalet's ARYMO ER for approval.

Eaglet Corp. recently reported that two U.S. Food and Drug Administration (FDA) advisory committees voted to recommend the approval of ARYMO ER. Read More »

Cancer drug delivery fast shifting, more changes likely

John Breslin | Jul 29, 2016

Jostling among hospitals, pharmacies, doctors, and third-party payers over the delivery of specialty cancer drugs is likely to intensify, according to experts observing the already fast shifting field of oncology treatment channeling. Read More »

FDA issues Acceptable for Filing letter for Sparsha’s Fentanyl Transdermal System

American Pharmacy News Reports | Jul 21, 2016

Lannett Company, Inc. recently announced that an Acceptable for Filing letter has been issued to its strategic partner Sparsha Pharma USA, Inc. from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System. Read More »

Congress passes prescription-drug bill targeting opioid abuse

Carol Ostrow | Jul 14, 2016

This week, Congress passed the Comprehensive Addiction and Recovery Act (CARA), which aims to combat prescription drug abuse, especially opioids. Read More »

FDA accepts new drug applications for Teva asthma medications

American Pharmacy News Reports | Jul 12, 2016

Fluticasone propionate/salmeterol and fluticasone propionate new drug applications accepted by FDA. Read More »

Harrisburg Rite Aid to relocate to Strawberry Square

American Pharmacy News Reports | Jul 5, 2016

Store scheduled to open in the mixed use complex in December. Read More »

Vasostrict patent approved by U.S. Patent and Trademark Office

American Pharmacy News Reports | Jul 5, 2016

Patent submitted to the FDA Orange Book for approval on June 28. Read More »

Endo Pharmaceuticals announces future FDA committee meeting

American Pharmacy News Reports | Jun 17, 2016

Endo Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has informed the company that an Advisory Committee will be meeting on its supplemental new drug application for OPANA ER. Read More »

Rite Aid opens Spartanburg distribution center

American Pharmacy News Reports | Jun 10, 2016

Rite Aid celebrated the opening of a new distribution center located in Spartanburg, S.C. this past week. Read More »

Kelly joins Adapt Pharma as President of U.S. Operations

American Pharmacy News Reports | Apr 13, 2016

Industry professional Mike Kelly joins Adapt Pharma; takes over U.S. operating activities. Read More »

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