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Will promised Orange Book guidance keep up with technology?

After more than a decade of industry pleading for guidance on Orange Book patent listings, the U.S. FDA is finally planning on answering that request this year. If the guidance that’s produced reflects the FTC’s position that device patents can’t be listed for combination products, it could overturn years of accepted practice and possibly hinder the development of new, more advanced drug administration technologies.

Orange-book , Guidance , Bioworld , Bioworld-medtech , Regulatory , Fda , Us- , Patents , Combination-drug-device , Combination-products , Astrazeneca-plc

lupin: Just coming to our own in India; confident of growing our US business in next fiscal year: Lupin management

Lupin's margin guidance remains around 19.5-20.5%. The company attributes its success to the pivot to complex products, cost-led initiatives, and positive factors like input cost tailwinds. However, there are potential negatives such as disruptions and freight costs that need to be considered. Lupin is just coming to its own in India and would want to replicate this growth.

Lucknow , Uttar-pradesh , India , Vinita-gupta , Ramesh-swaminathan , Nilesh-gupta , Indian-school-of-business , Offering-college , Head-corporate-affairs , Leadership-excellence , Executive-officer , Might-also-like

Lupin exploring demerger of API biz to unlock value

Lupin's peer Glenmark Pharma had undergone a similar exercise in May 2019, when the latter spun off its API business into a new entity called Glenmark Life Sciences, which made its public market debut in August 2021

India , China , Glenmark-pharma , Sanjay-singh , Vinita-gupta , Glenmark-lifesciences , Ramesh-swaminathan , Glenmark-life-sciences , Asia-healthcare , Production-linked-incentive , Lupin , Pi

Lupin sighs in relief over Spiriva approval, brokerages also cheer

Several brokerages have cheered US FDA's nod to Spiriva, an asthma inhaler, and expect it to aid margin recovery for Lupin in the medium term

Nithya-balasubramanian , Sanford-bernstein , Drug-administration-on , Boehringer-ingelheim , Spiriva-handihaler , Drug-administration , Institutional-equities , Axis-securities , Lupin , Spiriva , Espiratory-drug , Rug-approval

Lupin arm gets Health Canada nod to market generic version of Spiriva for COPD

Mumbai: Global pharma major Lupin Limited has announced that its Canada subsidiary, Lupin Pharma Canada Ltd., has received approval from Health Canada to market a generic version of Spiriva...

Japan , Canada , Mumbai , Maharashtra , India , Australia , Health-canada , Panel-nod-for-phase , Lupin-pharma-canada-ltd , Lupin-limited , Bromide-inhalation-powder

Detailed text transcripts for TV channel - MSNBC - 20150913:15:13:00

your throat or tongue swells, you get hives, vision changes or eye pain or problems passing urine, stop taking spiriva respimat and call your doctor right away. side effects include sore throat, cough, dry mouth and sinus infection. nothing can reverse copd. spiriva helps me breathe better. to learn about spiriva respimat slow-moving mist, ask your doctor or visit spirivarespimat.com everyone is looking for ways while to cut expenses.s unique, and that's where pg&e's online

Spain , Spiriva , Doctor , Nothing , Side-effects , Copd , Hives , Throat , Tongue , Problems , Vision-changes , Swells

Detailed text transcripts for TV channel - MSNBC - 20150913:16:28:00

spiriva helps me breathe better. to learn about spiriva respimat slow-moving mist, ask your doctor or visit spirivarespimat.com let's go to today's number ones. the first sunday of the nfl season. and that means high hopes for fans of all 32 teams. although, some hopes are higher than others. facebook analyzed comments on official team pages to determine the most optimistic and least optimistic nfl fans. kansas city chiefs have the rosiest outlook on the season. the only undefeated team in the preseason. the miami dolphin followers are almost as cheery about their team. the minnesota vikings have the third most positive fans. conversely, san diego fans are the most pessimistic. new england fans were second most down about their team, but that was before tom brady's suspension got the heave-ho. the pittsburgh steelers fans

Doctor , Spiriva , Mist , Spirivarespimat-com , Season , Comments , Fans , Others , Number-ones , Teams , Sunday , Hopes

Detailed text transcripts for TV channel - MSNBC - 20150913:12:58:00

where we divide head and heart, self and soul from the body. and i think if we think of the physical in our body is irrelevant to who we are. >> jewish new year. pastor, would you be willing to crib from his sermon there? >> i'm preaching this morning actually. >> what time? >> 11:30, 12:00. >> stay tuned for that. well-take a break here. we have other stories, not just bears and souls. but more poll results from msnbc and interview with tennis pro james blake. copd includes chronic bronchitis and emphysema. spiriva is a once-daily inhaled copd maintenance treatment that helps open my airways for a full 24 hours. spiriva helps me breathe easier. spiriva respimat does not replace rescue inhalers for sudden symptoms. tell your doctor if you have kidney problems, glaucoma, trouble urinating, or an enlarged prostate. these may worsen with spiriva respimat. discuss all medicines you take, even eye drops.

Pastor , Body , Being-jewish , Heart , Soul , Self , Sermon , Crib , Interview , Msnbc , James-blake , Bears

Detailed text transcripts for TV channel - FOXNEWS - 20150913:16:43:00

to breathe with copd?ow hard it can be it can feel like this. copd includes chronic bronchitis and emphysema. spiriva is a once-daily inhaled copd maintenance treatment that helps open my airways for a full 24 hours. spiriva helps me breathe easier. spiriva respimat does not replace rescue inhalers for sudden symptoms. tell your doctor if you have kidney problems, glaucoma, trouble urinating, or an enlarged prostate. these may worsen with spiriva respimat. discuss all medicines you take, even eye drops. if your breathing suddenly worsens, your throat or tongue swells, you get hives, vision changes or eye pain or problems passing urine, stop taking spiriva respimat and call your doctor right away. side effects include sore throat, cough, dry mouth and sinus infection. nothing can reverse copd. spiriva helps me breathe better.

Copd , Chronic-bronchitis , Emphysema , Spiriva , Symptoms , Airways , Treatment , Rescue-inhalers , 24 , Doctor , Medicines , Kidney-problems