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As­traZeneca, Mer­ck­'s star PARP in­hibitor Lyn­parza ex­pands reach in ovar­i­an can­cer with new US ap­proval

Weeks after GSK widened the market for PARP inhibitor Zejula in patients with ovarian cancer, rival AstraZeneca’s market-leading Lynparza has also secured expanded use in women with the disease.

Lynparza, in combination with Roche’s Avastin, has been approved by the FDA for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who have experienced a complete or partial response to first-line platinum-based chemotherapy and whose disease is associated with homologous recombination deficiency (HRD) positive status, defined by either a BRCA mutation and/or genomic instability. Roughly one in two women with advanced ovarian cancer has an HRD+ tumor.

No­var­tis lands cap­ma­tinib ap­proval, giv­ing them a sec­ond po­ten­tial block­buster from In­cyte

Over a decade after Novartis promised Incyte up-to $1.1 billion for a pair of early stage drugs, the second of the two has crossed the finish line.

The FDA has granted accelerated approval to capmatinib, a pill for non-small cell lung cancers with a METex14 mutation. The drug, now branded as Tabrecta, is the first drug approved to target patients with that mutation, which now joins ALK, RET, ROS and EGFR on the list of non-small lung cancers that can be treated with targeted therapies. Novartis estimates around 4,000 to 5,000 patients are diagnosed with METex14 positive NSCLC each year, or around 3% to 4% of all NSCLC patients.

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Com­mer­cial strat­e­gy for Gilead­'s Covid-19 drug-to-be remde­sivir re­mains opaque, as chief O'­Day em­pha­sizes re­spon­si­bil­i­ty

In his opening remarks on Thursday, Gilead chief Daniel O’Day did us all a favor, truncating his commentary on the quarter gone by to set aside more time to discuss in detail remdesivir: the compound at the heart of efforts to combat Covid-19.

But the big question remained — does Gilead plan to generate a return on its investment in the drug? O’Day did not answer that question directly, instead, he emphasized the need for responsibility.

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GSK widens the mar­ket for Ze­ju­la as FDA signs off on the PARP in­hibitor for use in ovar­i­an can­cer pa­tients with­out BR­CA mu­ta­tions

GSK has vastly expanded its market for cancer therapy Zejula — the crown jewel at the heart of its $5 billion acquisition of Tesaro — by winning FDA approval for the drug in a large subset of patients with ovarian cancer.

The approval comes for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who experienced a complete or partial response to first-line platinum-based chemotherapy — accounting for approximately 80% of all ovarian cancer patients.

Ver­tex's cys­tic fi­bro­sis drugs work, but they're too ex­pen­sive, ICER finds

Earlier this month, Reshma Kewalramani took over the reins as Vertex Pharmaceuticals’ CEO — she will now be tasked with grappling with criticism from cost-effectiveness watchdog ICER, which on Monday issued a report suggesting that despite the health gains offered by its suite of cystic fibrosis drugs, their prices are far too high to be sustainable for patients and health care systems.

“Despite being transformative therapies, the prices set by the manufacturer – costing many millions of dollars over the lifetime of an average patient – are out of proportion to their substantial benefits,” said David Rind, ICER’s chief medical officer in a statement.

Take­da auc­tions off a $670M port­fo­lio of drugs and man­u­fac­tur­ing ops, get­ting clos­er to its $10B goal

Takeda is $670 million closer to its goal of selling off $10 billion in assets to help pay for the Shire buyout.

The pharma giant reported Friday that it has sold off a portfolio of drugs and a pair of European manufacturing sites to Denmark’s Orifarm Group. The latest in a string of auctions, capped by the $5.3 billion sale of Xiidra to Novartis, Takeda has been systematically auctioning off bits of the company to pay down debt built in the acquisition.

Piv­otal da­ta ce­ment use of In­cyte, No­var­tis' rux­oli­tinib in dif­fi­cult-to-treat graft-ver­sus-host dis­ease

Allogeneic stem-cell transplants, in which patients are given stem cells harvested from a donor to replenish depleted supplies caused by radiation treatment or high doses of chemotherapy, are on the rise. But despite standard steroid therapy, acute graft-versus-host disease (GVHD), where the donor T cells attack host tissue, occurs in about half the patients and little progress has been made in developing an effective strategy to combat the life-threatening complication in the past three decades.

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Analy­sis shows Swiss biotech in­dex out­shines Nas­daq coun­ter­part, but coro­n­avirus chal­lenges are uni­ver­sal

In 2004, the Swiss Stock Exchange spawned its biotech index — the Swiss Bio+Medtech Index (SXI) — as the life sciences sector, headlined by large successful biopharma companies Roche and Novartis, took center stage. In the last five years through January 2020, SXI has produced returns of 59%, outperforming both the Swiss Performance Index (31%) and the NASDAQ Biotechnology Index (35%), a new analysis shows.

Over a year af­ter re­jec­tion, Im­munomedics emerges with po­ten­tial block­buster ap­proval

A turbulent 16 months for Immunomedics has ended in a potential blockbuster approval, as the FDA granted an accelerated OK for their drug to treat an aggressive form of breast cancer.

The drug, branded as Trodelvy, is approved for metastatic triple negative breast cancer — breast cancers that lack the oncogenes that targeted therapies go after and that have helped make the disease treatable for some patients. The drug, which had breakthrough status and priority review, showed a 33% response and median duration of response of 7.7 months in 108 patients enrolled in their Phase II trial. Peak sales estimates can range as high as around $3 billion.

Ab­b­Vie, J&J block­buster Im­bru­vi­ca rakes in 11th FDA ap­proval, as com­peti­tors work on erod­ing fran­chise

AbbVie and J&J’s market-leading Imbruvica, the original BTK inhibitor, continues to rake in approvals, while competition in the class of drugs heats up.

On Tuesday, the drug secured its 11th FDA approval. Imbruvica in combination with Roche’s rituximab has been sanctioned for use as the first line of defense in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).