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Research & Development

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Genentech Bets On Kineta's Early-Stage, Disease-Modifying Pain Therapy

Genentech partners with the Seattle biotech on a non-opioid approach to chronic pain. Kineta says there's disease-modifying potential.
Deals Neurology Commercial
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Clinical Trials

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Latest From Clinical Trials

Experts Challenge GSK Triple Inhaled COPD Therapy Claims

While GSK and collaborators publish findings from the IMPACT trial comparing once-daily single-inhaler triple versus dual therapy in patients with COPD in NEJM, two clinicians in an accompanying editorial argue that the trial falls short of providing robust evidence for switching strategy.

Clinical Trials Research & Development

With Back-To-Back FDA Holds, Solid Hopes To Regain Footing For Duchenne Candidate

The US FDA wants more information on the first patient given SGT-001, who was hospitalized with a reduced platelet count after dosing. Solid says the patient is doing well and hopes to reply to the FDA's concerns within weeks.
Research & Development Clinical Trials

In The Hot Seat: Bristol Defends IO Position Amid Sliding Stock And Forecasts

Bristol's stock price dipped after the AACR meeting, where pivotal lung cancer data for Opdivo/Yervoy disappointed relative to Merck's Keytruda/chemo combo, but Bristol still has many immuno-oncology irons in the fire in other indications and expressed confidence in its strategy.

Clinical Trials ImmunoOncology

Roche's IMpower150 Gets AACR Applause But Merck's KEYNOTE-189 Big Winner

Roche’s Tecentriq IMpower150 trial showed Tecentriq plus Avastin plus paclitaxel and carboplatin significantly improved progression free survival compared to Avastin and chemo alone; overall survival data will be coming later this year.

Clinical Trials Cancer

ImmuPharma Puts On Very Brave Face After Lupus Drug Flop

Shares in the UK biotech have fallen through the floor following a failed Phase III trial of Lupuzor but ImmuPharma remains surprisingly upbeat about the lupus drug's prospects.

Immune Disorders Clinical Trials

Hanmi Halts Olmutinib Development After Alliances Crumble

Hanmi is set to focus on other assets in its innovative drug pipeline after it ends development of novel lung cancer drug olmutinib amid ZAI Lab’s recent cancellation of a licensing agreement with the South Korean pharma.

Research & Development Clinical Trials
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Approvals

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Latest From Approvals

Ultragenyx Gets Second Drug Approval; Crysvita With Kyowa Hakko Kirin

Ultragenyx already has a sales team in place to market its second commercial drug Crysvita (burosumab) – partnered with Kyowa Hakko Kirin – following its April 17 FDA approval for the treatment of pediatric and adult patients with x-linked hypophosphatemia (XLH).

Approvals Launches

Rigel Readies Tavalisse For Late-May Launch After FDA Approval

Rigel has its first US FDA approval for Tavalisse (fostamatinib) and plans to launch the drug for adults with immune thrombocytopenia (ITP) in late May, after working on the drug's development for more than a decade across multiple indications.

Approvals Immune Disorders

Pipeline Watch: Phase III Top-Line Results With Upadacitinib, Keytruda And Cosentyx

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

 


Pipeline Watch Approvals

Pacira Sees Big Opportunity In Exparel's Narrow Nerve Block Indication

Brachial plexus indication for long-acting bupivacaine liposome will launch in US with combined 2,000-rep sales force under copromotion with J&J; although Pacira did not get the broad claim requested, company sees significant commercial opportunity for an indication that is expected to encompass 60% of all nerve block procedures within the next two years.

Approvals Advertising, Marketing & Sales

FDA Tells RegeneRx It Needs 3rd Phase III Trial On RGN-259 For Dry Eye Syndrome

The FDA is requiring an additional RGN-259 Phase III trial to further show efficacy in both signs and symptoms of dry eye in a larger patient population.

Analysis Approvals

Roche Seen Offering NICE Further Price Cut For MS Drug Ocrevus

UK HTA provisionally tells Roche price for supplying MS blockbuster Ocrevus to the NHS not good enough – 'try again'.

Approvals Commercial
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Post Marketing Regulation & Studies

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Latest From Post Market Regulation & Studies

Repatha Inroads Build Gradually As EU Extension Nears

Europe is expected to follow where the US led in expanding the label for Amgen's PCSK9 inhibitor Repatha to include a prevention indication for heart attacks and strokes. But growth will be hard-won.

Approvals Cardiovascular

Biogen, AbbVie Withdraw Struggling MS Drug Zinbryta Due To Safety Issues

Antibody was approved in the US with a liver safety warning while EU regulators recently limited the drug's use. Now, EMA has begun an urgent review of reports of inflammatory brain disorders related to Zinbryta.
Drug Safety Post Market Regulation & Studies

Siliq Probably Isn't The Light At The End Of Valeant's Tunnel

Valeant is touting Siliq to lead new product growth, but the drug's significant safety concerns in a competitive psoriasis market likely will offset efficacy advantages it could offer.

Drug Safety Risk Management

Nearing Finish Line, HCV Race Focuses On Salvage Therapy

With few remaining unmet needs in hepatitis C, Gilead, Merck and AbbVie are focusing on tough-to-treat niches with their next-gen combination regimens, especially treatment-experienced patients who failed on prior direct-acting antiviral therapy. Merck also is studying injectable drug users in an effort to eradicate HCV entirely.

Infectious Diseases Liver & Hepatic

Intercept Seeks Long-Term Data To Build Ocaliva Market In PBC

The FXR agonist is the first new drug approved for primary biliary cholangitis in 19 years, but the lack of long-term outcomes data leaves a perceived opportunity for a host of mid-stage candidates also pursuing the indication. Intercept is conducting a Phase IV study to obtain such data with Ocaliva.

Commercial Business Strategies

Off-Label Communication: Pfizer Highlights Burdens Of FDA Policy

Seeking relaxation of US agency restrictions, Pfizer cites three examples where company delayed or decided against distributing medically relevant information beyond the product labeling; PhRMA survey shows almost half of all requests for information by prescribers and payers relate to off-label use.

Regulation Advertising, Marketing & Sales
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