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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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

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.

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.

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.

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.

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.