Ahead of the German major's fourth-quarter earnings call Feb. 27, analysts at Bernstein have been weighing up Bayer's chances of surviving the patent expiries on Xarelto and Eylea.

The move follows a similar price cut for Amgen's competing PCSK9 inhibitor Repatha and comes as PBMs, including UnitedHealth Group's OptumRx, are looking for ways to maintain the drug rebate status quo.

Joe Dupere, CEO at Rexgenero, reveals to Mike Ward during Biotech Showcase 2019 the four-year-old UK biotech’s plans. 

Scrip looks back at the studies released in 2018 and highlights trials that had a large impact, for better or worse.

Fixed-dose combination of phentermine and topiramate is FDA-approved for chronic, long-term use, but the average duration in the real world is only about 2.1 months, which is reassuring for Qsymia’s cardiovascular safety, according to a new retrospective claims study.

Biotech regains full rights to a pair of targeted therapies for heart diseases, but will bear full development costs. MyoKardia says the agreement with Sanofi ended due to differences over commercial rights, not concerns about trial data.

In its latest TANGO trial for chronic lower back pain, Eli Lilly and Pfizer’s tanezumab has shown efficacy at 10 mg, but its 5 mg dose missed the statistically significant mark. Vitally, analysts are encouraged by safety data.

With sales of its largest-selling product under threat from generic competition, a couple of new products and cost cuts are put forward to reinvigorate Indivior, a leader in addiction therapies.

In another globally pioneering move, Japan approves a trial with its flagship iPS cell technology in spinal cord injury, following a controversial earlier marketing approval in the same indication.

Shire puts in solid results in last full year before Takeda acquisition, with 4% sales growth and strong cash flow, but there was some weakness in hematology stemming from lower ex-US prices and rising competition.

Rexulti failed in two Phase III trials to statistically separate from placebo in bipolar I manic episodes.

Committee overwhelmingly supports approval for treatment-resistant depression but warns that pricing and combination therapy indication could hinder patient access. Esketamine’s risks of sedation and dissociative effects, and its abuse potential, will necessitate a strict risk management strategy.

Analyst speculates that risk of pulmonary embolism for a higher unapproved of Xeljanz in arthritis could trigger a label change for the same regimen in the drug's ulcerative colitis indication.

Shire puts in solid results in last full year before Takeda acquisition, with 4% sales growth and strong cash flow, but there was some weakness in hematology stemming from lower ex-US prices and rising competition.

Paul Peter Tak recently defected from big pharma to East Coast venture firm Flagship Pioneering. He described the appeal of entrepreneurship in the biotech world and the value of taking the road less traveled when it comes to biomedical R&D.

The Swiss giant has posted a strong set of results with the company highly confident that its flagship immune drug can keep the competition at bay.

But German Biotech says court summary judgement will have no bearing on MorphoSys's own CD38 antibody MOR202.

At J.P. Morgan, AbbVie said the clinical struggles of Rova-T won’t alter its deal-making plans and leave it with plenty of solid tumor possibilities. The pharma took a $4bn write-off of the Stemcentrx deal on Jan. 4.

Building on a leading position in anti-infectives research, Evotec aims to develop a new class of antibacterials based on cystobactamids, which are found in slime bacteria and have potent activity against serious bacterial pathogens.

Hit with a complete response letter from the US FDA for its antibiotic to treat ABSSSI, Motif needs to raise funds and fast to stay afloat and prepare a meeting package to discuss the next steps for iclaprim with the agency.

Melinta describes difficulties launching its new antibiotics at BIO CEO & Investor Conference; companies and other stakeholders urge Congress to enact package of incentives to reinvigorate antibiotic pipeline.

Funded entirely by grants and partnerships to date, Affinivax’s pneumococcal vaccine candidate has begun a Phase I/II study less than five year’s after the biotech’s founding. Firm thinks its technology may eventually apply to immuno-oncology as well.

Thomas Lingelbach talks to Scrip about Valneva’s plans for a US IPO to fund Phase III studies of its lead Lyme disease vaccine.

CEO Ken Frazier had to argue the case that Merck has a diversified portfolio in yet another strong quarter for the PD-1 inhibitor Keytruda.

With four new entrants readying to be prescribed in the next four years, the market for diabetic nephropathy is looking more buoyant than ever. However, competition from GLP-1 agonists and eventually from generics could put a dampener on proceedings.

Belgium’s Galapagos adds another potential fibrosis drug to its growing pipeline of compounds in a therapeutic area that is also attracting attention from a number of other companies.

Danish diabetes fighter will file oral semaglutide with FDA within months using a priority review voucher to reduce the time for expected approval to six months.

New approvals in the EU were again dominated by oncology drugs in 2018, although medicines for infectious diseases were a close second. The number of orphan drugs more than doubled over the previous year, to 17. There were also some star arrivals in multiple sclerosis, genetic disorders, metabolism and migraine.

A small Cambridge, UK-based company, which is more at home partnering with the pharma industry than competing with it, is readying its run into the diabetes space with its ultra-rapid acting insulin. Scrip talked to its CEO to about the company’s biggest year yet.

Scrip journalists asked industry executives, consultants and analysts what they believe the big themes, trends and events will be in 2019. Here's what they told us about advances in therapeutic technologies and areas of clinical innovation.

Updated data from PIVOT-02 at the ASCO GU meeting suggest a path for accelerated approval of the NKTR-214/Opdivo combination as first-line treatment of patients with PD-L1-negative urothelial cancers.

When buying Loxo, Lilly highlighted the importance of LOXO-292, a first-in-class oral RET inhibitor, rather than the already-approved Vitrakvi, perhaps knowing that partner Bayer was going to be exercising an option to take full control of the TRK inhibitor.

In the latest round of what appears to have been a bruising set of price negotiations for Roche, the UK’s cost effectiveness agency NICE has recommended Perjeta in another breast cancer setting.

ASCO GU: Darolutamide is important for the company's oncology portfolio, but does it have enough to compete against J&J's Erleada and Pfizer/Astellas' Xtandi?

The drug major has presented a set of financials that have comfortably surpassed analyst forecasts and show that its new oncology therapies now make up around 30% of group sales and are growing strongly.

Clinigen's planned purchase of US rights to Proleukin will give it global ownership of the IL-2 drug.

Two weeks after the product's approval, Mylan finally has launched Wixela and revealed a big price cut for the asthma and COPD medicine over the brand; the actual savings for patients remains dependent on payer negotiations and other factors.

GSK said its oncology pipeline has doubled in size since July to include 16 assets in the clinic and highlighted the newly in-licensed bifunctional immunotherapy M7824.

After regulatory talks, revamped Redx gets green light to resume clinical study of RXC004 in patients with advanced solid tumors, while sister porcupine inhibitor RXC006 is set to enter IPF trials in 2020, the biotech's CEO tells Scrip.

Verona’s shares sank after a brief three-day Phase II trial using lead asset RPL554 in patients already maximally bronchodilated on both a LAMA and LABA missed the primary endpoint.

The Imutex joint venture between hVIVO and the SEEK Group updates promise of its universal flu vaccine candidate after additional data from a Phase IIb study showed a statistically significant effect on its primary endpoint.

With a steady stream of royalties coming in from Flutiform and Ultibro and a decent pipeline of innovative respiratory drugs and generics, Vectura has presented a promising update for the year ahead.