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"AbbVie antibody drug conjugate misses mark Phase trial∨derfield=date∨derval=DESC" News Stories

00:24 EDT 24th July 2019 | BioPortfolio

Here are the most relevant search results for "AbbVie antibody drug conjugate misses mark Phase trial∨derfield=date∨derval=DESC" found in our extensive news archives from over 250 global news sources.

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Showing "AbbVie antibody drug conjugate misses mark Phase trial" News Articles 1–25 of 29,000+

Wednesday 24th July 2019

FDA Approves Samsung Bioepis' HADLIMA™ (adalimumab-bwwd)

Samsung Bioepis secures third FDA approval in the past seven months Samsung Bioepis becomes the first company to receive FDA approvals for biosimilars referencing all three first-generation anti-TNF medicines. Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has approved HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA® i (adalimumab), ...


Tuesday 23rd July 2019

Jubilant Cadista Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, Due to Out-of-Specification Dissolution Test Results

Jubilant Cadista Pharmaceuticals Inc. is voluntarily recalling one lot of Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/ 0.02mg, 28x3 Blister Pack/Carton to the consumer level. The affected product is being recalled due to out-of-specification (OOS) dissolution results at the 3-month stability time point. The affected product is manufactured by Cyndea Pharma, S.L., Olvega (Soria), 42110 S...

STAT caught up with Claire McCaskill to talk about drug prices, President Trump’s bold rhetoric on the issue, and what lobbying looks like when you’re a U.S. senator. https://buff.ly/2Y3i2sb 

STAT caught up with Claire McCaskill to talk about drug prices, President Trump’s bold rhetoric on the issue, and what lobbying looks like when you’re a U.S. senator. https://buff.ly/2Y3i2sb 


FDAnews Announces — Get Pre-Certified: Software as a Medical Device Webinar, August 1, 2019

Is the software a medical device? Get certified to be ahead of the competition. FALLS CHURCH, Va. (PRWEB) July 23, 2019 Is there some way to bring a software as a medical device (SaMD) product to market faster? The answer is yes, with the Software Precertification Program. The pre-cert pathway regulatory model expedites pre-market approval while assessing the safety and effectiveness of software ...

Drug development on a chip

Scientists of Karlsruhe Institute of Technology (KIT) have found a way to combine the separate steps required for drug development, hence facilitating and accelerating the search for promising new substances. Their work has been published in the journal Nature Communications. The early phase of drug development is traditionally based on three areas of science, beginning when chemists synthesise a...

FDAnews Announces — Drug Pricing and Reimbursement: Navigating the Changes, Anticipating the Future Webinar, August 6, 2019

Expert explains drug pricing/reimbursement issues triggered by new policies. Learn to apply to product development, commercialization plans. FALLS CHURCH, Va. (PRWEB) July 23, 2019 “For too long it’s been virtually impossible for Americans to know the real price and quality of healthcare services and the services they receive. With today’s historic action, we are fundamentally changing the ...

E. coli superbug can live in women’s gut without symptoms

Virulent and multi-drug resistant strains of Escherichia coli can thrive in women’s gut even without any symptoms, a new study found.

Merck's biosimilar to AbbVie's Humira wins FDA approval

The U.S. Food and Drug Administration approved Merck & Co Inc's biosimilar to AbbVie Inc's blockbuster rheumatoid arthritis treatment Humira, the health agency said on Tuesday.

Veristat Expands Operations into Taiwan to Support Growing Client Demand for Clinical Trial, Biostatistics and Programming Excellence in the Region

Opens office in Taipei, Taiwan Veristat, a scientifically oriented clinical development, and regulatory submission partner, announces the formal launch of its Clinical Trial, Biostatistics and Programming operations in Taipei, Taiwan with the opening of a

111 Wins Recognition as Pioneer of New Healthtech

"Growth Champion" Award for "1 Drugstore" SHANGHAI, June 23, 2019 /PRNewswire/ -- 111, Inc. (NASDAQ: YI) ("111" or the "Company"), a leading integrated online and offline healthcare platform, today announced that its online retail pharmacy "1 Drugstore" has won two prestigious industry awards. Both awards, "2018-2019 Top 100 Pharmacy Chains i...

The FDA has canceled an outside committee's review of Intra-Cellular's schizophrenia drug, causing shares to tumble. https://buff.ly/2GstsuB 

The FDA has canceled an outside committee's review of Intra-Cellular's schizophrenia drug, causing shares to tumble. https://buff.ly/2GstsuB 

Frequently requested or proactively posted drug-specific and other records

Frequently requested or proactively posted drug-specific and other records

EZ Weight Loss TX LLC Issues Voluntary Nationwide Recall of Atomic and Xplode Capsules Due to the Presence of Undeclared Sibutramine

Corpus Christi, TX, EZ Weight Loss TX is voluntarily recalling all lots of La Bri's Body Health Atomic and Xplode capsules to the consumer level. FDA analysis has found the products to be tainted with sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons. The presence of sibutramine in these products renders it an unapproved ...

Cantrell Drug Company Issues Voluntary Nationwide Recall of All Sterile Drug Products Due to Lack of Sterility Assurance

Cantrell Drug Company is voluntarily recalling all lots of unexpired sterile drug products to the hospital and user level due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide, except to the states of Connecticut, Hawaii, South Carolina and Vermont. To date, Cantrell has not received any reports of adverse events.

Senators announce bipartisan proposal to lower drug prices

The top Republican and Democrat on the U.S. Senate Finance Committee announced a proposal to lower prescription drug prices on Tuesday that could save $100 billion in costs to government healthcare programs, and said the committee would vote on the l...

Vertex Submits NDA to the FDA for Triple Combination Regimen of VX-445, Tezacaftor and Ivacaftor in Cystic Fibrosis

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination regimen. The NDA includes a request for Priority Review, which, if granted, would shorten the FDA’s review of the NDA to eight ...

Takeda’s Investigational Subcutaneous Formulation of Vedolizumab Meets Primary Endpoint in its Phase 3 Crohn’s Disease Trial

OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced top-line results from the VISIBLE 2 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of the gut-selective biologic vedolizumab as maintenance therapy in adult patients with moderately to severely active Crohn’s ...

FDA Approves Celgene’s Otezla for the Treatment of Oral Ulcers Associated with Behçet’s Disease

SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has approved OTEZLA® (apremilast) 30 mg twice daily (BID) for the treatment of adult patients with oral ulcers associated with Behçet’s Disease. OTEZLA, an oral, selective inhibitor of phosphodiesterase 4 (PDE4), is the first and only approved treatment o...

Boehringer's Ofev Faces Efficacy Hurdle For SSc-ILD Indication At US FDA Advisory Cmte.

The Arthritis Advisory Committee will give its take on Boehringer Ingelheim's forced vital capacity data as the drugmaker seeks to...   

FDA cancels panel review of $ITCI schizophrenia drug, causing shares to tumble https://www.statnews.com/2019/07/23/fda-cancels-panel-review-of-intra-cellulars-schizophrenia-drug-causing-shares-to-tumble/ … There's a third possible explanation, too: FD

FDA cancels panel review of $ITCI schizophrenia drug, causing shares to tumble https://www.statnews.com/2019/07/23/fda-cancels-panel-review-of-intra-cellulars-schizophrenia-drug-causing-shares-to-tumble/ … There's a third possible explanation, too: FDA already decided to approve the drug. Could the market be mis-reading?

Ligand Acquires Ab Initio Biotherapeutics, an Antigen-Discovery Company

Strengthens and expands its OmniAb platform offering Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces the signing of an agreement with Ab Initio Biotherapeutics whereby Ligand will acquire Ab Initio for $12 million in cash. Ab Initio was a privately held antigen-discovery company based in South San Francisco, California. Antigen design and preparation are the first steps necessary fo...

Dallas Gets Infusion Center to Treat Depression, PTSD, Chronic Pain & Addiction

Principal Spine and Pain Consultants partners with Kalypso Wellness Centers to provide Dallas residents with a new pain management treatment option for their patients DALLAS (PRWEB) July 23, 2019 Kalyspo Wellness Centers, one of the nation’s leading providers of ketamine infusions, has partnered with Principal Spine and Pain Consultants in Dallas, TX to bring Kalypso’s patent pending ketamine...

Antibe Therapeutics Announces Offering of Units

NOT FOR DISTRIBUTION OR DISSEMINATION INTO THE UNITED STATES OR THROUGH U.S. NEWSWIRE SERVICES Antibe Therapeutics Inc. (“Antibe” or the “Company”) (TSXV: ATE, OTCQB: ATBPF), a leader in developing safer therapeutics for pain and inflammation, today announced that it has filed a preliminary short form prospectus (the “Preliminary Prospectus”) in connection with a proposed marketed of...

Gilead Announces Latest Data in Ongoing HIV Cure Research Program

– New Studies Evaluate Agents with Potential Role in Eliminating HIV Viral Reservoir – Gilead Sciences, Inc. (NASDAQ: GILD) today presented results from two studies of investigational toll-like receptor 7 (TLR7) agonists as part of an HIV cure research program. The Phase 1 and preclinical study results demonstrate that the TLR7 agonists vesatolimod (GS-9620) and GS-986 can induce immune acti...

Capricor Therapeutics (CAPR) Update - PPMD Webinar Commentary (HOPE-2 Results) & Raising Funds

AbstractOn Wednesday, July 17, 2019, CEO Linda Marban of Capricor Therapeutics (CAPR) held a webinar for the Parent Project Muscular Dystrophy (PPMD) to discuss the positive interim results from its HOPE-2 Trial. The webinar provided additional color as Dr. Marban fielded questions regarding: an FDA approval path; and additional context on the results.At the end of last week, CAPR appeared to sett...


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