Legal/Regulatory

Judge's ruling allows Sandoz to begin marketing its biosimilar Zarxio

Judge's ruling allows Sandoz to begin marketing its biosimilar Zarxio

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The motion denied Amgen's bid for a temporary injunction that would have prevented the launch of Zarxio, the first FDA-approved biosimilar and a competitor to Amgen's Neupogen.

Five things for pharma marketers to know: Monday, August 31

Five things for pharma marketers to know: Monday, August 31

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Kim Kardashian posts corrective information on Instagram and Twitter; DPP-4 inhibitors are linked to joint pain; doctors question off-label prescriptions of PCSK9 inhibitors

Five things for pharma marketers to know: Thursday, August 27

Five things for pharma marketers to know: Thursday, August 27

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The FDA releases biosimilar-naming draft guidance; PD1 drugs linked to a rare type of diabetes; Amgen's PCSK9 inhibitor faces approval decision

Five things for pharma marketers to know: Tuesday, August 25

Five things for pharma marketers to know: Tuesday, August 25

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US patent office declines to review two Ampyra patents; the FDA expands indication for Promacta; the Biosimilars Council argues against CMS proposal for biosimilar coding

Five things for pharma marketers to know: Friday, August 21

Five things for pharma marketers to know: Friday, August 21

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The FDA encourages clinical testing of testosterone; Google spins out its life-sciences business; Novartis buys remaining rights to Arzerra

Poll: Majority of Americans support government negotiation of drug prices

Poll: Majority of Americans support government negotiation of drug prices

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A new poll conducted by the Kaiser Family Foundation found that most Americans believe drugmakers should be required to release information to the public about how they set drug prices.

Editor's Desk: Kim Kardashian West's tempest in a bottle

Editor's Desk: Kim Kardashian West's tempest in a bottle

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Could Kardashian West's now-notorious Diclegis social post be more than an OPDP case study?

Amgen settles off-label case with states

Amgen settles off-label case with states

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State attorneys general accused the drugmaker of violating state consumer protection laws.

What to expect in wake of the Amarin ruling: more truthful off-label talk from pharma

What to expect in wake of the Amarin ruling: more truthful off-label talk from pharma

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But don't expect the floodgates to open. Marketers still have to take a legal route to promote such information.

Five things for pharma marketers to know: Monday, August 17

Five things for pharma marketers to know: Monday, August 17

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Court blocks generic competition for Opana ER until 2023; lawmakers question Valeant drug price hikes; Roche's immuno-oncology drug meets primary endpoint in mid-stage trial

Five things for pharma marketers to know: Thursday, August 13

Five things for pharma marketers to know: Thursday, August 13

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The FDA pushed back Opdivo's PDUFA date in light of new data; lawmakers argue about vet co-pays; Merck and MD Anderson Cancer Center to evaluate Keytruda in stomach and liver cancers

Bad ad watchdog slams Kardashian's social-media post

Bad ad watchdog slams Kardashian's social-media post

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The FDA said Kim Kardashian West's promotion of morning-sickness pill Diclegis misbranded the product by understating its risks.

Five things for pharma marketers to know: Tuesday, August 11

Five things for pharma marketers to know: Tuesday, August 11

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"Me-too" drugs may help lower costs; start-ups send doctors to your home; the FDA is likely to appeal the Amarin ruling

Judge grants relief to Amarin in off-label case

Judge grants relief to Amarin in off-label case

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The decision, a setback for the FDA, allows the drugmaker to move forward with plans to legally promote some off-label information.

FDA okays 3-D print technology for drug

Spritam is a prescription epilepsy adjunct delivered orally.

Five things for pharma marketers to know: Tuesday, July 28

Five things for pharma marketers to know: Tuesday, July 28

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Sanofi plans immuno-oncology collaboration with Regeneron; Merck considers hard-to-treat patient populations for its experimental hepatitis-C therapy; drugmakers did not report 10% of adverse events to the FDA within required timeframe

Praluent's FDA review looms, but questions persist

Praluent's FDA review looms, but questions persist

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A next-generation cardiovascular drug is expected to be approved this week, but concerns abound about who will take it—and how much it will cost.

Five things for pharma marketers to know: Wednesday, July 22

Five things for pharma marketers to know: Wednesday, July 22

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Experimental Alzheimer's disease drugs produce mixed results; court rules in favor of Novartis in Zarxio case; Horizon Pharma increases its bid for Depomed

CMS updates CME guidance

CMS updates CME guidance

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New rules will require manufacturers to report some indirect payments made to physicians for CME activities.

Five things for pharma marketers to know: Thursday, July 16

Five things for pharma marketers to know: Thursday, July 16

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The FDA discusses working with Google to identify unknown drug side effects; Tavenner named chief of insurer lobby group; drugmakers are starting to use cultural experts to better understand patient experience.

21st Century Cures, Amarin Court Case Advance

21st Century Cures, Amarin Court Case Advance

Pharma's efforts to evolve restrictions about off-label marketing move forward.

House expected to vote on 21st Century Cures

House expected to vote on 21st Century Cures

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The legislation would allow drugmakers to share information about their products beyond what is included on the FDA-approved label.

Five things for pharma marketers to know: Thursday, July 9

Five things for pharma marketers to know: Thursday, July 9

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Pregnant women taking Prozac or Paxil have higher risks of birth defects; study finds J&J's experimental psoriasis drug works better than Humira; AstraZeneca divests global rights to Entocort

Novartis exec: Pharma culture can be stumbling block to creativity

Novartis exec: Pharma culture can be stumbling block to creativity

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It's not always regulation or concerns about legal risks. Sometimes, a drugmaker's internal conservative culture is the biggest hurdle to overcome.

Public health officials to distribute Truvada in fight against HIV

Los Angeles County voted in favor of adding the drug to the public health program's repertoire in fighting HIV and AIDS.

Five things for pharma marketers to know: Wednesday, June 10

Five things for pharma marketers to know: Wednesday, June 10

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FDA panel recommends Sanofi/Regeneron's PCSK9 inhibitor for approval; Merck and Samsung collaboration says their rheumatoid arthritis biosimilars are equivalent to the biologic versions; Bayer offloads its diabetes-care business

Five things for pharma marketers to know: Monday, June 1

Five things for pharma marketers to know: Monday, June 1

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Bristol-Myers Squibb's Opdivo serves up lukewarm lung-cancer results; new cancer drugs are too expensive, Sloan Kettering oncologist tells ASCO attendees; Teva settlement could stymie industry use of pay-for-delay patent tactics

Court orders Actavis to keep Namenda IR on market

An appeals court affirmed an earlier ruling that Actavis must keep an older formulation of its Alzheimer's drug, Namenda, on the market.

21st Century Cures bill advances to House floor

21st Century Cures bill advances to House floor

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The legislation would allow drugmakers to share economic information with payers beyond what is included on the FDA-approved label.

Five things for pharma marketers to know: Wednesday, May 20

Five things for pharma marketers to know: Wednesday, May 20

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FDA official says DTC risk claims are a waste of time; one analyst believes Afrezza could turn around sluggish sales; J&J inks billion-dollar deal to commercialize HCV drugs


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