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Sandra Horning speaks at an Endpoints News event during the #JPM19 healthcare conference (Jeff Rumans for Endpoints News)

Roche boosts can­cer ap­provals in Eu­rope, push­ing for a big­ger slice of the I/O pie

Roche is stacking up approvals for its flagship checkpoint inhibitor in the lucrative field of lung cancer. On Friday, the Swiss drugmaker revealed that the European Commission had endorsed the use of Tecentriq in combination with chemotherapy as the first line of defense in certain patients with advanced non-squamous non-small cell lung cancer (NSCLC).

The approval comes on the basis of the 723-patient IMpower130 study, which tested the drug plus chemo against chemo alone, in patients with stage IV metastatic non-squamous NSCLC, who are not carrying EGFR or ALK mutations.

The 'mind-blow­ing' R&D re­nais­sance in psy­che­del­ic meds finds a home at Johns Hop­kins

The “mind-blowing” field of psychedelic research is getting its first major US home, one that could help legitimize a field that has slowly crept out of the shadows over the last two decades.

Johns Hopkins Medicine announced Wednesday they are opening what they believe to be the first center for psychedelic research in the country and the largest in the world.

The Center for Psychedelic and Consciousness Research at Johns Hopkins Medicine will include a team of 11 faculty scientists and post-docs investigating the potential use of LSD and psilocybin (the chemical found in magic mushrooms) — among other psychedelics — to impact human creativity and well-being and to treat a host of disorders, including opioid addiction, Alzheimer’s disease and PTSD.

Mallinck­rodt preps a pos­si­ble bank­rupt­cy amid a mael­strom of opi­oid claims — re­port

Struggling with $5 billion in debt and a maelstrom of legal claims over their alleged role in a nationwide epidemic of opioid abuse, Mallinckrodt has reportedly been consulting with lawyers and restructuring pros to see if they should restructure the company in bankruptcy.

Bloomberg reported that the biopharma company — frequently fingered as one of the worst players involved in price gouging — has hired Latham & Watkins along with AlixPartners to explore their options. And that triggered a rout as investors fled the stock $MNK, sending its shares down 44% after the bell.

The phar­ma in­dus­try's rep hits ab­solute. rock. bot­tom.

After two years of being pilloried by the president and lawmakers for drug pricing, sparking headlines about huge judgments levied for triggering the opioid epidemic (J&J) and hiding manipulated data during an FDA review (Novartis), it may come as no surprise to hear that the industry’s reputation has suffered some.

But it’s worse than that.

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Ko­re­an bio­phar­ma ex­ec­u­tive in­dict­ed for al­leged­ly con­duct­ing il­le­gal tri­als on com­pa­ny re­searchers

Korean news outlets are reporting that an executive at a major Korean pharmaceutical company has been arrested for conducting illegal clinical tests on company researchers.

Citing the Seoul Western District Prosecutors’ Office and other officials, The Korea Times reported that Auh Jin of Ahn-Gook Pharmaceutical was arrested for carrying out illegal tests on the company’s own researchers in violation of the country’s pharmacy law. The Korea Herald similarly reported that Jin had been arrested.

Dan Polster, AP Images

US judge paves way for brand­ed and gener­ic opi­oid mak­ers to face land­mark Oc­to­ber tri­al

A US judge has thwarted efforts by major drug manufacturers, distributors and pharmacies to reject claims that they played a pivotal role behind the opioid crisis that has ravaged the United States.

In doing so, district judge Dan Polster has cleared the path for a scheduled landmark trial, even as he pushes for a nationwide settlement, noted a Reuters report on Tuesday. Polster is presiding over more than 2,000 opioid lawsuits filed by states, counties and cities. Opioid-related overdoses have claimed almost 400,000 lives from 1999 to 2017, the CDC estimates.

As­traZeneca's di­a­betes drug Farx­i­ga cuts risk of CV death or wors­en­ing of heart fail­ure by 26% in land­mark study

About two weeks after AstraZeneca’s $AZN unveiled its diabetes treatment Farxiga cut the risk of CV death or the worsening of heart failure in patients with heart disease, in a landmark trial — over the weekend the British drugmaker presented detailed data at the European Society of Cardiology (ESC) Congress in Paris.

The results emanated from the 4,744-patient DAPA-HF trial, which tested Farxiga in patients with reduced ejection fraction (HFrEF) — in which the heart muscle is not able to contract amply and, therefore, expels less oxygen-rich blood into the body — on standard of care treatment, including those with and without type-II diabetes.

Medicines Company CEO Mark Timney [via YouTube]

A new PC­SK9 play­er draws rave re­views for in­clisir­an. Can a mar­ket­ing war with Am­gen be far be­hind?

The Medicines Company $MDCO waded directly into the middle of one of the most bitterly contested fields in biopharma today using a detailed set of efficacy and safety data from their Phase III study of inclisiran to build a case that their drug can whip 3 heavyweight rivals deep into the troubled PCSK9 game.

Just don’t expect the new CEO running things at the company to say much about that rivalry.

Top-lined a few days ago, the efficacy numbers posted at the European Society of Cardiology’s ESC Congress in Paris line up where the analysts had hoped, with a 54% relative reduction in LDL tied to the drug arm compared to placebo — which ranks up there with the high 50s hit by Repatha (Amgen) and Praluent (Regeneron and Sanofi). Just as importantly, the safety data on exhibit Monday look pristine, with an adverse event profile that tends to mirror the control arm along with no evidence of added toxicity — a feature that will encourage everyone in RNAi to go deeper into diseases with massive patient populations after establishing themselves in rare diseases.

There’s even some exploratory cardio data — which will have to be confirmed in a huge, ongoing outcomes study — to help back up their expectations for a competitive benefit on MACE and strokes that payers will want to see proved beyond a reasonable doubt.

The numbers back up a good set of odds on a near-term OK for inclisiran in 2020, provided a nasty surprise isn’t in wait along the sidelines. If so, they’ll be readying a rollout now that will take aim against two of the most touted drugs that ever fell far short of their mark.

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Alex­ion hit by sur­prise in­ter partes re­view as Am­gen chal­lenges Soliris patents

Amgen is coming for Alexion — but not in the form of a rumored, and largely dispelled, takeover.

Rather, the US Patent Trials Appeal Board (PTAB) has agreed to conduct an inter partes review on Alexion’s Soliris. Amgen, which is pushing a biosimilar to the complement inhibitor, filed the IPR in an effort to overturn patents on the composition eculizumab (the active ingredient in Soliris), its formulation, and its use to treat certain diseases, including the key indication of paroxysmal nocturnal hemoglobinuria.

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Worst. biotech. deal. ever? Turns out Ab­b­Vie has plen­ty of com­pe­ti­tion for that ti­tle

Buying any late-stage drug in a biotech buyout can be fraught with danger — and ripe for humiliation. AbbVie got a lesson on that with the final failure for Rova-T, a drug they forked over $5.8 billion in cash and equity to get its hands on.

But was this the worst. biotech. deal. ever?

I pitched that notion on Twitter and got a ton of feedback from everyone pointing out Teva’s disastrous generics buyout from Allergan, which tipped the company into a revenue spiral, to the Gilead and Celgene deals for Kite and Juno (thank you, Brad Loncar).

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